BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1935184 · Received December 22, 2010

    Report

    Report Number
    1823260-2010-07617
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 11, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE STRIPS HAD EXPIRED.

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN COMPACT PLUS METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: 151 MG/DL (COMPACT PLUS) AND 77 MG/DL (DOCTOR'S METER) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 20719841

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR FISH OIL| WALKER| ASPIRIN| LISINOPRIL| INSULIN N| INSULIN R| SIMVASTATIN| VITAMIN D