BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 3912480 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04881
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    March 5, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH WITH IDENTIFIER (B)(6) IS CUSTOMER'S COMPACT PLUS SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS WIFE'S COMPACT PLUS SYSTEM. STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CUSTOMER FELT SYMPTOMS OF HYPOGLYCEMIA WITH A RESULT OF "160-200" MG/DL ON HIS COMPACT PLUS SYSTEM, RETESTED WITH WIFE'S COMPACT PLUS SYSTEM, RESULT WAS 60 MG/DL. NO TREATMENT WAS REPORTED. NO ADVERSE EVENT WAS REPORTED. STRIPS ARE NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390505 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR HUMULIN N| HUMULIN R