BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1001768 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01659
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 9, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING BLOOD GLUCOSE TEST RESULTS OF 286 MG/DL BACK TO BACK WITH A RESULT OF 64 MG/DL ON THE COMPACT PLUS SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT SHE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED THAT SHE SELF-TREATED WITH ORANGE JUICE AND CRACKERS. NO OTHER ACTIONS WERE TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE 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 LFR ROCHE DIAGNOSTICS 20665142

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR TRAZODONE - OVER 2 YRS - 150MG 2-3 TABS ONCE DAILY| FUROSEMIDE - OVER 2 YEARS - 40 MG ONCE DAILY| OYSTER SHELL - OVER 2 YEARS - 500 MG TWICE DAILY| ABILIFY - OVER 2 YEARS - 5 MG ONCE DAILY| LOVASTATIN - OVER 2 YEARS - 40 MG ONCE DAILY| LANTUS - OVER 2 YEARS - 40 UNITS ONCE DAILY| PROTONIX - 2 WEEKS - 40 MG ONCE DAILY| FLUOXETINE HCL - OVER 2 YEARS - 20 MG ONLY DAILY| CLONIDINE - OVER 2 YEARS - 0.1 MG TWICE DAILY| "HYDROCO/APAP" - 1 YEAR - 5-500 MG AS NEEDED| VITAMIN D - FEW MONTHS - 5000 UNITS ONCE WEEKLY| LISINOPRIL - OVER 2 YEARS - 20 MG TWICE DAILY| METOPROLOL - OVER 2 YEARS - 50 MG TWICE DAILY| HUMALOG - OVER 2 YRS - SLIDING SCALE 3 TIMES DAILY| FOSAMAX - OVER 2 YEARS - 70 MG ONCE WEEKLY| ACTOS - OVER 2 YEARS - 45 MG ONCE DAILY| LASIX - TIME UNK - 80 MG