BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2800144 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01568
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT SHE BELIEVES THE PATIENT'S INFUSION DEVICE DELIVERS TOO LITTLE INSULIN. THE PATIENT IS (B)(6). ON (B)(6) 2012, AT 8:00 AM THE PATIENT'S BLOOD GLUCOSE MEASURED 277 MG/DL AND HE ATE 3 KE AND THE MOTHER ATTEMPTED TO BOLUS 3.3 UNITS OF INSULIN AND AFTER 0.5 UNITS AN E4 (OCCLUSION) ERROR WAS DISPLAYED. AT 10:00 AM THE PATIENT'S BLOOD GLUCOSE MEASURED 324 MG/DL AND THE PATIENT WAS GIVEN 0.5 UNITS OF INSULIN. AT 12:00 PM THE PATIENT'S BLOOD GLUCOSE MEASURED 164 MG/DL AND HE ATE 2.5 KE AND THE MOTHER ADMINISTERED 1.5 UNITS OF INSULIN. AT 2:30 PM THE PATIENT'S BLOOD GLUCOSE MEASURED 322 MG/DL AND HE ATE 2.5 KE AND THE MOTHER ADMINISTERED 1.5 UNITS OF INSULIN. AT 5:00 PM THE PATIENT'S BLOOD GLUCOSE MEASURED 225 MG/DL, AT 6:00 PM THE MOTHER CHANGED THE INFUSION SET. AT 7:00 PM THE PATIENT'S BLOOD GLUCOSE MEASURED 290 MG/DL AND THE MOTHER ADMINISTERED 0.5 UNITS OF INSULIN, THE PATIENT ATE 3.8 KE AND WAS GIVEN AN ADDITIONAL 2.9 UNITS OF INSULIN. AT 9:00 PM THE PATIENT'S BLOOD GLUCOSE MEASURED 289 MG/DL AND THE MOTHER ADMINISTERED 0.5 UNITS OF INSULIN. AT 10:00 PM THE PATIENT'S BLOOD GLUCOSE MEASURED 269 MG/DL AND AT 11:00 PM HIS BLOOD GLUCOSE MEASURED 279 MG/DL. THE INFUSION DEVICE, INSULIN CARTRIDGE, AND INFUSION SET WERE REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| DATE OF THERAPY: UNK| INSULIN