BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1842729 · Received September 23, 2010

    Report

    Report Number
    1823260-2010-05643
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED CONSECUTIVE HIGH BG READINGS (378-446MG/DL) WITHIN THE FIRST DAY OF ACTIVATING THE POD, WHICH PROMPTED HER TO ADMINISTER A BOLUS AS WELL AS A MANUAL INSULIN INJECTION. HER BG SUCCESSFULLY LOWERED OVER THE FOLLOWING FOUR HOURS. WHEN THE POD WAS REMOVED, SHE OBSERVED "NOTICEABLE KINKING ON THE CANNULA"; DESPITE THE KINK, NO ALARM HAD BEEN INITIATED. THE POD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED A HYPOGLYCEMIC EPISODE WHERE THE CUSTOMER REQUIRED INTERVENTION. CUSTOMER WAS "OFF BALANCE" AND WAS FOUND IN THE KITCHEN ON THE FLOOR. WIFE CALLED THE (B)(6) AND EITHER RIGHT BEFORE OR WHILE SHE WAS ON THE PHONE WITH THE VA NURSE, THE WIFE OBTAINED A READING OF 116 MG/DL ON THE CUSTOMER WITH HIS METER. WIFE ATTEMPTED TO TREAT THE CUSTOMER WITH HONEY BUT CUSTOMER COULD NOT GET THE HONEY IN HIS MOUTH. SHE THEN TRIED BROWNIES AND SUGAR WATER. THE CUSTOMER WAS ABLE TO CONSUME THIS AND GET INTO THE CAR TO DRIVE TO THE (B)(6) HOSPITAL 90 MILES AWAY. WHILE IN ROUTE TO THE (B)(6), THE CUSTOMER HAD BROWNIES, A (B)(6), AND MORE HONEY. WIFE REPORTS THAT THE CUSTOMER TESTED AT 230 MG/DL UPON ARRIVAL AT THE (B)(6). THE READING OF 116 MG/DL DID NOT MATCH THE CUSTOMER'S SYMPTOMS. 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 302614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention