BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3242372 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01352
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 14, 2013
    Report Date
    September 25, 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
    GM
    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. THE ADAPTER'S OUTSIDE AND THREAD IS DIRTY, WHICH MEANS HANDLING COULD BE HINDERED AND FUNCTIONALITIES ARE NOT ENSURED. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE BATTERY COVER PASSED THE OPTICAL INSPECTION.

    Description of Event or Problem · 1

    MOTHER REPORTED THE PATIENT EXPERIENCED HYPERGLYCEMIA OF 480 MG/DL AND KETOSIS ON (B)(6) 2013. HE FELT SICK AND NAUSEOUS AND HE VOMITED. HIS MOTHER DROVE HIM TO THE HOSPITAL, AND HIS BLOOD GLUCOSE WAS 500 MG/DL. HE WAS TREATED WITH AN INSULIN INFUSION AND BY THE INFUSION DEVICE. HE CHANGED TO THE BACKUP INFUSION DEVICE ON (B)(6) 2013 AFTER INCREASING THE BASAL RATES. HIS BLOOD GLUCOSE RETURNED TO NORMAL, AND HE WAS SCHEDULED TO BE DISCHARGED FROM THE HOSPITAL THE NEXT DAY. PATIENT'S PHYSICIAN AND MOTHER DO NOT TRUST THE INSULIN DELIVERY OF THE PRIMARY INFUSION DEVICE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342555 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 016 YR Hospitalization| R BAYER CONTOUR BLOOD GLUCOSE METER| NOVARAPID INSULIN