BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ADVANTAGE TEST STRIPS

    MDR report key: 2989928 · Received March 5, 2013

    Report

    Report Number
    1823260-2013-01311
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 27, 2013
    Report Date
    April 15, 2013
    Manufacturer
    NA
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED CUSTOMER'S WIFE TESTED CUSTOMER ON HIS ADVANTAGE SYSTEM AND RECEIVED A RESULT OF 9.3 MMOL/L AT AN UNKNOWN TIME. THE CUSTOMER WAS "FEELING UNWELL" AT THAT TIME. A "SHORT TIME" AFTER, THE WIFE CALLED THE AMBULANCE AS CUSTOMER'S HEALTH WAS "BECOMING WORSE". THE PATIENT RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM COMPARED TO A PROFESSIONAL METER WITHIN 1 MINUTE: 9.3 MMOL/L (ADVANTAGE) AND 2.0 MMOL/L (PROFESSIONAL METER). THE CUSTOMER WAS TREATED WITH AN UNSPECIFIED GLUCOSE PRODUCT. APPROXIMATELY 40 MINUTES LATER THE AMBULANCE PERSONNEL TESTED THE CUSTOMER AGAIN ON THEIR PROFESSIONAL METER AND RECEIVED A RESULT OF 4.5 MMOL/L. THE AMBULANCE DEPARTED THE RESIDENCE AT THAT TIME. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92974 ACCU-CHEK ® ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR NA NA 571727

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR