BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOASSAY, VITAMIN B12

    MDR report key: 2122991 · Received June 14, 2011

    Report

    Report Number
    1823260-2011-03245
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDD
    PMA / PMN Number
    K060755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC CAUSE. TESTING PERFORMED USING THE SAME LOT NUMBERS OF REAGENT AS THE USER DID NOT CONFIRM THE IMPRECISION. RECOVERY OF CONTROLS WAS WITHIN SPECIFICATION AND THE SAMPLES RECOVERED WELL. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER EXPERIENCED A PRECISION ISSUE AND RECEIVED QUESTIONABLE VITAMIN B12 RESULTS FROM THE COBAS E411 SERIAL NUMBER (B)(4) WHEN THE SAMPLES WERE TESTED WITH TWO DIFFERENT REAGENT PACKS FROM THE SAME LOT. OF THE DATA PROVIDED, THE RESULTS FOR ONE PATIENT SAMPLE WERE DISCREPANT. THE RESULT FROM REAGENT PACK NUMBER 14481 WAS 112.4 PG/ML AND THE RESULT FROM REAGENT PACK NUMBER 8783 WAS 238.4 PG/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN HAD EXPRESSED DOUBT ABOUT THE RESULT AND ASKED THAT IT BE RECHECKED. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOASSAY, VITAMIN B12 VITAMIN B12 CDD ROCHE DIAGNOSTICS NA 160807-01

    Patients

    Seq Age Sex Outcome Treatment
    1 029 YR