BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 311

    MDR report key: 4162228 · Received October 10, 2014

    Report

    Report Number
    1823260-2014-07779
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PDJ
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER BUT WAS NOT PROVIDED. PRE- ANALYTICAL ISSUES WERE EXCLUDED AS A CAUSE. ALTHOUGH QUALITY CONTROLS WERE WITHIN RANGE ON THE DAY OF THE EVENT, AN ISSUE WITH THE REAGENT CASSETTE COULD NOT BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.2 (HBA1C) RESULT FOR ONE PATIENT ON THEIR C311 ANALYZER. THE CUSTOMER STATED THEY SUSPECTED THE HBA1C REAGENT PACK WAS THE PROBLEM AND REPLACED IT. THE SAMPLES TESTED IN THE MORNING WITH THE SAMPLE IN QUESTION WERE NOT REPEATED, BUT THE SAMPLES RUN IN AFTERNOON WHEN THE REAGENT PACK WAS REPLACED WERE REPEATED. THIS WAS THE ONLY SAMPLE IN QUESTION. THE PATIENT'S INITIAL HBA1C RESULT WAS 7.9% AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE RESULT WAS QUESTIONED ON 09/30/2014 BY THE PHYSICIAN. THE PATIENT TOLD THE PHYSICIAN THAT SHE HAD NEVER HAD A HIGH HBA1C RESULT BEFORE, SO A REDRAW WAS MADE. ON (B)(6) 2014, THE RESULT FROM THE SECOND SAMPLE WAS 5.8%. ON (B)(6) 2014, THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 5.8%. THE REPEAT RESULT WAS CONSIDERED CORRECT. THERE WERE NO ADVERSE EVENTS. THE HBA1C REAGENT LOT NUMBER WAS 69127401 AND THE EXPIRATION DATE WAS (B)(6) 2015. THE CUSTOMER DECLINED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639974 COBAS 311 CLINICAL CHEMISTRY ANALYZER PDJ ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR