BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2191273 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02119
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 20, 2011
    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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT REPORTED THE VIBRATION ALARM ON THE INFUSION DEVICE HAS BEEN DEFECTIVE SINCE SHE STARTED USING THIS INFUSION DEVICE ON (B)(6) 2011. PT REPORTED THERE IS NO VIBRATION ALARM FOR THE FIRST 2 UNITS OF A BOLUS THAT IS PROGRAMMED, AND THEN THE VIBRATION ALARM WORKS PROPERLY FOR THE REST OF THE BOLUS DELIVERY. IF PT SELECTS THE BOLUS FUNCTION, THE INFUSION DEVICE DOES NOT PROVIDE THE VIBRATION ALARM TO INDICATE THE FUNCTION IS READY FOR AN INPUT. THIS MOST RECENTLY OCCURRED ON (B)(6) 2011. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR INSULIN INFUSION SET| INSULIN