BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3242357 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01350
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 17, 2013
    Report Date
    September 3, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE INVESTIGATION SHOWED THAT THE BATTERY ACID LEAKED OUT OF THE BATTERY. THE ACID LED TO CORROSION ON THE BATTERY CONTACTS AND TO A POWER INTERRUPTION. THE INSULIN PUMP COULD NOT BE STARTED AGAIN BECAUSE OF THE CORRODED BATTERY CONTACTS. THE USER OF AN ACCU-CHEK SPIRIT COMBO INSULIN PUMP SHOULD ONLY USE QUALITY BATTERIES.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE FAILED TO PROVIDE AN ERROR MESSAGE WHEN INSULIN WAS NOT DELIVERED. SHE PROGRAMMED A BOLUS AT 5:30 PM AND BEGAN TO FEEL SICK, AND HER BLOOD GLUCOSE HAD ELEVATED TO "HI" AT 9:30 PM SHE WAS ADMITTED TO THE HOSPITAL AND TREATED WITH AN INSULIN INFUSION. SHE STARTED TO USE A HOSPITAL INFUSION DEVICE, AND HER BLOOD GLUCOSE WAS 7.0 MMOL/L (126 MG/DL) THE NEXT MORNING. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342518 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 023 YR Hospitalization| R