BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022507 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02889
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 30 MG/DL ON HIS DAUGHTER WHILE USING THE AVIVA SYSTEM WHILE SHE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS. REPORTER STATED THAT SHE WAS IN THE HOSPITAL AND THE NURSE THEN OBTAINED A RESULT OF 127 MG/DL ON THE HOSPITAL'S ADVANTAGE SYSTEM WITHIN 10 MINUTES OF 30 MG/DL ON THE AVIVA SYSTEM. REPORTED STATED THE NURSE THEN TREATED HIS DAUGHTER WITH A SHOT OF GLUCOSE IN HER IV. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT. THE HOSPITAL LOCATION/CONTACT INFORMATION COULD NOT BE DETERMINED, THUS NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention TOPAMAX / TIME AND DOSAGE UNK| LANTUS - 72 UNITS NIGHTLY| NOVOLOG - SLIDING SCALE