BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2861021 · Received December 3, 2012

    Report

    Report Number
    2183996-2012-01848
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 25, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. E7 (ELECTRONIC) ERROR WERE FOUND IN THE HISTORY AND CORRECTLY TRIGGERED. THE VIBRATOR MOTOR DOES NOT FUNCTION. AN INTERNAL DEFECT OF THE VIBRATOR LED TO THE PROBLEM.

    Description of Event or Problem · 1

    THE PATIENT REPORTED E7 (ELECTRONIC) ERROR WAS DISPLAYED ON THE INFUSION DEVICE AND SHE WAS UNABLE TO CLEAR THE ERROR. SHE THEN CHANGED THE BATTERY AND INSULIN CARTRIDGE AND WAS ABLE TO START THE INFUSION DEVICE NORMALLY. ON (B)(6) 2012 AT 8:00AM THE MOTHER REPORTED THAT THE INFUSION DEVICE STOPPED WORKING DURING THE NIGHT AND THE PATIENT'S BLOOD GLUCOSE ELEVATED AND SHE WAS NAUSEOUS AND WAS VOMITING. THE PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL AND HER BLOOD GLUCOSE MEASURED 14.5 MMOL/L (261 MG/DL). WHEN SHE ARRIVED AT THE HOSPITAL HER BLOOD GLUCOSE MEASURED 17.5 MMOL/L (315 MG/DL). SHE WAS TREATED WITH AN INFUSION OF DEGAN AND INSULIN AND HER BLOOD GLUCOSE DECREASED TO 8-10 MMOL/L (144-180 MG/DL). THE INFUSION DEVICE WAS REPLACED AND 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 Hospitalization| R AND RELATED ACCESSORIES| INSULIN| INSULIN PUMP