BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1912140 · Received December 2, 2010

    Report

    Report Number
    1823260-2010-07085
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 27, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2. (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 200 MG/DL ON COMPACT PLUS SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 87 MG/DL ON COMPACT PLUS SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER ALSO ALLEGED OBTAINING AN ESTIMATED RESULT OF 399 MG/DL ON COMPACT PLUS SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 167 MG/DL ON COMPACT PLUS SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES, AT A SEPARATE TIME. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED THAT THE STRIPS ARE NO LONGER AVAILABLE, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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
    1 076 YR CARVEDILOL (TWICE DAILY)| HUMULIN N| ASPIRIN (DAILY)| HUMALOG