BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAMIN B12

    MDR report key: 2283181 · Received October 7, 2011

    Report

    Report Number
    1823260-2011-05312
    Event Type
    Malfunction
    Date Received
    October 7, 2011
    Date of Event
    September 22, 2011
    Report Date
    January 26, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDD
    PMA / PMN Number
    K060755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS THE VITAMIN B12 REAGENT. THE SITE HAS 25 IMMUNOASSAY ANALYZERS. IT WAS UNCLEAR WHICH ANALYZER GENERATED THE RESULTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER INDICATED NO FURTHER INFORMATION WILL BE AVAILABLE. THE SITE INDICATED THERE ARE NO CURRENT PROBLEMS WITH THE ANALYZER OR THE B12 ASSAY. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE VITAMIN B12 RESULTS FOR 37 PATIENT SAMPLES. THE EXACT DATE OF TESTING WAS NOT KNOWN. THE INITIAL RESULTS WERE <31 PG/ML FOR ALL PATIENT SAMPLES AND THE REPEAT RESULTS FROM AN ANALYTICAL E MODULE WERE ALL IN THE NORMAL REFERENCE RANGE OF 211-946 PG/ML. THE EXACT REPEAT RESULTS WERE NOT AVAILABLE. ALL OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT. IT WAS UNKNOWN IF THE PATIENTS WERE ADVERSELY AFFECTED. THE VITAMIN B12 REAGENT LOT NUMBER WAS NOT PROVIDED. NO SERVICE VISIT WAS PERFORMED AS THERE WERE NO CURRENT ISSUES WITH THE SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 028 YR