BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 2890836 · Received December 31, 2012

    Report

    Report Number
    1823260-2012-06606
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    November 19, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACTIVE SYSTEM WITHIN 10 MINUTES: 222 MG/DL AND 68 MG/DL. CUSTOMER FELT HER BLOOD SUGAR WAS LOW AND WAS ABLE TO SELF-TREAT WITH GLUCOSE TABLETS AND FOOD. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 23448532

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR CAPTOPRIL 2X DAILY| HUMALOG 3X DAILY| ATORVASTATIN| VITAMIN D| MULTIVITAMIN GENERIC BRAND 1X DAILY