BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1190331 · Received October 6, 2008

    Report

    Report Number
    1823260-2008-07381
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK AVIVA SYSTEM 1. REFERENCE MEDWATCH WITH A1 PATIENT FOR SUSPECT DEVICE ACCU-CHEK AVIVA SYSTEM 2.

    Description of Event or Problem · 1

    THE CALLER STATES THAT THE CUSTOMER EXPERIENCED AN EVENT WHERE HE WAS INCOHERENT, "OUT OF IT" AND DID NOT KNOW WHAT WAS GOING ON. THE CUSTOMER'S BLOOD GLUCOSE WAS 90MG/DL ON THE ACCU-CHEK AVIVA SYSTEM. THE CALLER ATTEMPTED TO TREAT THE CUSTOMER WITH ORANGE JUICE. THE CALLER WAS UNSUCCESSFUL. WITHIN 10 MINUTES THE CUSTOMER'S BLOOD GLUCOSE WAS 45 MG/DL ON THE PROFESSIONAL METER. THE EMERGENCY MEDICAL TECHNICIAN'S TREATED THE CUSTOMER WITH GLUCOSE. THE RESULTS OF THE TREATMENT UNDISCLOSED. THE CUSTOMER EXPERIENCED ANOTHER EVENT WHERE THE BLOOD GLUCOSE RESULTS OF 214 MG/DL AND "HI" (GREATER THAN 600 MG/DL) WERE OBTAINED ON THE ACCU-CHEK AVIVA SYSTEM WITHIN A 10 MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NEW SYSTEM SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 301315

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Required Intervention GLIPIZIDE| LANTUS