BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C ASTL/PYP

    MDR report key: 3688584 · Received March 19, 2014

    Report

    Report Number
    1823260-2014-01913
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    December 9, 2013
    Report Date
    April 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEW INFORMATION HAS BEEN PROVIDED. THE DATE RECEIVED BY MANUFACTURER, WAS (B)(4) 2014. THE NEW INFORMATION PROVIDED FOR THIS CASE INDICATES THE INITIAL MDR REPORT WAS SUBMITTED BY ROCHE DIAGNOSTICS PAST THE 30 DAY TIMELINE AS REQUIRED PER 21 CFR 803. THIS EVENT OCCURRED ONLY ONCE AND NO OTHER TESTS WERE AFFECTED. THE DISCREPANT RESULT WAS REPORTED OUTSIDE THE LABORATORY. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. CALIBRATION BEFORE AND AFTER THE EVENT WAS ACCEPTABLE. THE QUALITY CONTROL WAS SLIGHTLY OUT OF RANGE ON (B)(6) 2103, WHEN THE QUESTIONABLE RESULT WAS GENERATED. THE WASHING STATION WAS CHECKED AND FOUND TO BE OK. THERE WERE INDICATIONS THAT THE HIGH DOSE HOOK-EFFECT WAS INVOLVED IN PRODUCING THE QUESTIONABLE RESULT. THIS LIMITATION IS COVERED IN THE PACKAGE INSERT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THERE WAS A QUESTIONABLE ASPARTATE AMINOTRANSFERASE ACC TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST) RESULT FOR ONE PATIENT ON A C501 ANALYZER. ON (B)(6) 2103, THE PATIENT HAD A SAMPLE TESTED AND THE AST RESULT WAS 9413 IU/ML. ON (B)(6) 2013, THE PATIENT HAD A SECOND SAMPLE TESTED AND THE RESULT WAS 595 IU/ML. ON (B)(6) 2103, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL HAD AN AST RESULT OF 12000 IU/ML. THE SECOND HOSPITAL CALLED THE FIRST HOSPITAL QUESTIONING HOW THESE DIFFERENT RESULTS COULD HAPPEN. THE FIRST HOSPITAL REPEATED THE SAMPLE FROM (B)(6) 2013 AND THE RESULT WAS 726 IU/ML ACCOMPANIED BY A TEST FLAG. THE SAMPLE WAS REPEATED WITH DILUTION AND THE RESULT WAS 11727 IU/ML. THE CUSTOMER STATED: "THE PEDIATRICIAN HAS, IN CONSULTATION WITH THE MICROBIOLOGIST CONCLUDED THAT THE (UNJUSTIFIED) DECREASE OF AST VIRTUALLY PROBATIVE WAS FOR A STREPTOCOCCI INFECT". INFORMATION ON WHETHER THE DISCREPANT RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE AST REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOR PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162172 COBAS C ASTL/PYP NADH OXIDATION/NAD REDUCTION, AST/SGOT JJE ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 015 YR BROXIL CAPS| CLARITROMYCINE