BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1172517 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07041
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 109 MG/DL BACK TO BACK WITH A RESULT OF ABOUT 30 MG/DL ON THE ACTIVE S SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIA SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT. REPORTER STATED THE CUSTOMER NO LONGER HAS THE STRIPS AND SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR NOVOLOG- 2 YEARS| LANTUS - 2 YEARS - 10 UNITS NIGHTLY