Events

Rappel de ADVIA Chemistry XPT System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Healthcare Diagnostics, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72391
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0755-2016
  • Date de mise en oeuvre de l'événement
    2015-10-07
  • Date de publication de l'événement
    2016-02-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140892
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Multiple software issues. auto start-up fail, calibration interval resets when a reagent blank is run, control definition screen assumes range defined is 2 sd, laboratory information system (lis) communication/laboratory automation (las) issue, printer driver resets, ise calibration ranges are too conservative for urine sodium, archiving and deletion may fail and workstation services may restart.
  • Action
    On October 7, 2015 Siemens Healthcare Diagnostics distributed Urgent Field Safety Notices to their custoemrs via Fed Ex in the U.S. and via email to regional countries for implementation outside of the U.S. Customers were provided a work-around if they have experienced any of the following problems: 1) Intermittent auto-startup function fails, 2) calibration interval resets as though a full calibration was performed, 3) Users may be unaware that the QC definition screen with +/- suggests a 2 Standard Deviation range value, 4) a rescanned and re-queried sample may become stuck in a communication loop and all tests may read as "inprocess" if the the initial reaction process is incomplete, 5) The printer stops printing if multiple printouts are requested in quick succession, 6) the ISE calibration for Urine Sodium (Na) may fail due to the ranges being set conservatively during development, 7) The automatic or manually started, archiving and deletion maintenance activity may fail and 8) A workstation services restart screen may appear under multiple scenarios causing the interface to be temporarily inaccessible. If customers have experienced any of the previously mentioned workflow problems, please perform the following actions: 1. Auto Start Failing: Manually perform the Startup Wash, run controls and any calibrations that are due. 2. Calibration interval resets when an RBL is run: Calibration should be run according to the recommendations in the Instructions for Use (IFU) for each assay. Keep a record of required calibrations and ensure that all assays are calibrated before use. 3. Control definition screen assumes that the range is defined as 2 SD values: When creating QC definitions, enter the values associated with a +/- 2 Standard Deviation (SD) range in the +/- ranges field.4. Laboratory Information System (LIS) communication / Laboratory Automation (LAS) issue: Be aware of errors in the event log and take action as needed. Manual intervention and rerunning

Device

ADVIA Chemistry XPT System
  • Modèle / numéro de série
    Software Version 1.0.3
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) in states of: AZ, CA, MA, NY, TX & WA, and to countries of: Bahrain, Egypt, Slovakia, France, Spain, Italy, Norway, Singapore, New Zealand, Germany, Australia, Republic Korea, Netherlands, Denmark, Finland & United Kingdom.
  • Description du dispositif
    ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 || Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA