BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2855052 · Received December 3, 2012

    Report

    Report Number
    1823260-2012-06076
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 4, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 RESULTS OF 438 MG/DL AND 115 MG/DL, WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT 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 20733746

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR BENICAR| CRESTOR| QUINAPRIL| ASPIRIN - 1X A DAY| VITAMIN D - 1X/MONTH| FERROUS SULFATE| FOLIC ACID| METFORMIN| CLONIDINE| MELOXICAM - 1X/DAY| AMLODIPINE