BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1801825 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04855
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 3, 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
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE COMPACT PLUS SUSPECT SYSTEM USED. (B)(4)

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED THE RESULTS OF ABOUT 300 MG/DL AND 33 MG/DL ON THE AVIVA SYSTEM COMPARED BACK TO BACK WITH THE RESULTS OF 87 MG/DL AND 127 MG/DL ON THE COMPACT PLUS SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT SHE GAVE THE CUSTOMER SOMETHING TO INCREASE HIS BLOOD GLUCOSE LEVELS PRIOR TO THE LAST RESULT OF 127 MG/DL. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR LANTUS (DAILY)| HUMALOG (3 TIMES DAILY)