BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C (701) MODULE

    MDR report key: 6797275 · Received August 16, 2017

    Report

    Report Number
    1823260-2017-01710
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 16, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR CA2 CALCIUM GEN.2 (CA2), HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION (HDLC3) OR GGT ¿-GLUTAMYLTRANSFERASE (GGT) ON A COBAS 8000 C (701) MODULE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL HDLC3 RESULT WAS 0.046 MMOL/L. THE REPEAT RESULT WAS 1.408 MMOL/L. PATIENT 1 INITIAL CA2 RESULT WAS 0.024 MMOL/L. THE REPEAT RESULT WAS 2.280 MMOL/L. PATIENT 2 (FEMALE, (B)(6) YEARS) INITIAL GGT RESULT WAS 0.11 UKAT/L. THE REPEAT RESULT WAS 1.226 UKAT/L. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE HDLC3 REAGENT LOT NUMBER WAS 200769 WITH AN EXPIRATION DATE OF 07/31/2018. THE CA2 REAGENT LOT NUMBER WAS 221425 WITH AN EXPIRATION DATE OF 05/31/2018. THE GGT REAGENT LOT NUMBER WAS 243277 WITH AN EXPIRATION DATE OF 01/31/2018. NO CALIBRATION WAS PERFORMED ON THE DAY OF THE EVENT FOR THE AFFECTED TESTS. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE CALIBRATION TRACE. QUALITY CONTROL RESULTS FROM THE DAY OF THE EVENT WERE ACCEPTABLE. A REVIEW OF THE ALARM TRACE SHOWS 5 ABNORMAL ASPIRATION ALARMS ON (B)(6) 2017 BETWEEN 9:40 A.M. AND 11:37 A.M. BASED ON DATA PROVIDED, THE AFFECTED PATIENT SAMPLES WERE PIPETTED BETWEEN 11:00 A.M. AND 11:30 A.M. THE PATIENT SAMPLES WERE PIPETTED DURING THE TIME THE ABNORMAL ASPIRATION ALARMS OCCURRED. IT IS LIKELY THAT THE SAMPLE PROBE WAS CONTAMINATED BY THE SAMPLE WHICH WAS GENERATING THE ABNORMAL ASPIRATION ALARMS. THE CUSTOMER HAS NOT COMPLAINED OF ANY FURTHER ISSUES. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A SAMPLE QUALITY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577291 COBAS 8000 C (701) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR