BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2223503 · Received August 25, 2011

    Report

    Report Number
    1823260-2011-04573
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    September 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE STATES THAT THE CUSTOMER ATTEMPTED TO USE HIS AVIVA METER, BUT OBTAINED AN ERROR MESSAGE, AND SUBSEQUENTLY HAD A HYPOGLYCEMIC EVENT. CUSTOMER ATTEMPTED TO USE THE DEVICE WITHIN 24 HOURS OF THE INCIDENT. CUSTOMER FELT LOW SYMPTOMS OF INCOHERENCE AND INABILITY TO SPEAK, AND COULD NOT TREAT HIMSELF. CUSTOMER'S WIFE TREATED HIM WITH A "GLUCOSE SHOT." CUSTOMER FELT BETTER WITHIN 10 MINUTES. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303112

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR Required Intervention