BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1970525 · Received January 25, 2011

    Report

    Report Number
    1823260-2011-00388
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(4).

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 336 MG/DL AND 154 MG/DL BACK TO BACK WITHIN 10 MINUTES ON COMPACT PLUS SYSTEM 1. REPORTER ALSO ALLEGED THAT ON A DIFFERENT DAY, SHE OBTAINED A RESULT OF 154 MG/DL ON COMPACT PLUS SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 56 MG/DL ON COMPACT PLUS SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR AVANDIA| DIABETA| LIPITOR| "ANATRIPOLIN"| HYDROCHLOROTHIAZIDE| NARVOX| "ACAPOROL"| METOPROLOL| PRANDIN| BLOOD PRESSURE MACHINE