BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1792067 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04729
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULT OF 266 MG/DL. THE CUSTOMER TOOK AN EXTRA GLIPIZIDE 5MG TABLET BASED ON THE READING. SAME SYSTEM RETEST RESULT WAS 106 MG/DL WITHIN 5 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE HEIGHT ADJUSTMENT AT THE FOOT END DID NOT LOCK IN. DURING TRANSFER, THE FOOT END OF THE COT SLID COMPLETELY DOWN. NEITHER THE PATIENT, WHO WAS STILL ON THE COT, NOR THE PARAMEDICS WERE INJURED.

    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 20725648

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR GLIPIZIDE 2XDAY| TOPROL 3XDAY