BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1800442 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04820
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT HAD BEEN FOUND DEAD IN HIS BATHROOM AND SHE FEELS HIS DEATH MAY HAVE BEEN CAUSED BY THE "DEFECTIVE DEVICE." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 130 MG/DL AND 290 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CUSTOMER ALSO HAD A HYPOGLYCEMIC EVENT THAT REQUIRED TREATMENT. CUSTOMER STATES THAT HE OBTAINED A READING OF 201 MG/DL, AND TOOK 60 UNITS OF NOVOLOG, INSTEAD OF 60 UNITS OF LANTUS, PRIOR TO GOING TO BED. CUSTOMER STATED THAT HE PICKED UP THE WRONG VIAL OF INSULIN, WHICH CAUSED HIS HYPOGLYCEMIC EVENT. AT 2:00 A.M., THE CUSTOMER'S WIFE FOUND HIM "SPEAKING IN TONGUES AND RAMBLING." THE WIFE GAVE THE CUSTOMER ORANGE JUICE, AND HE FELT BETTER IN ABOUT AN HOUR. DURING THE EVENT, THE CUSTOMER'S WIFE OBTAINED THE FOLLOWING SEVERAL READINGS WITHIN 26 MINUTES ON THE AVIVA SYSTEM. THESE READINGS WERE OBTAINED AFTER THE CUSTOMER WAS TREATED WITH ORANGE JUICE: 37 MG/DL, 37 MG/DL, 36 MG/DL, 70 MG/DL, 44 MG/DL, 48 MG/DL, 47 MG/DL, 214 MG/DL, AND 114 MG/DL 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 302384

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR NOVOLOG| LANTUS