BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2913459 · Received December 21, 2012

    Report

    Report Number
    2183996-2012-02007
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 17, 2012
    Report Date
    June 11, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. E7002 ERRORS WERE FOUND IN THE HISTORY. THE VIBRATOR MOTOR DOES NOT FUNCTION, AND AN INTERNAL DEFECT OF THE VIBRATOR LED TO THIS PROBLEM.

    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 RECEIVING AN E7 (ELECTRONIC ERROR) MESSAGE ON THE INFUSION DEVICE. PT REPORTED RECEIVING AN E7 RANDOMLY FOR 3-4 MONTHS BUT IS UNABLE TO CLEAR THE E7 NOW. PT STATED SHE RECEIVED A NEW SERVICE PACK THIS MORNING AND PLACED A NW BATTERY IN THE INFUSION DEVICE AND THE E7 REMAINS. PT REPORTED THAT WHEN THE INFUSION DEVICE GOES THROUGH START-UP MODE, THE DEVICE DOES NOT VIBRATE. PT STATED THE DEVICE HAS NEVER VIBRATED. PT REPORTED THE BATTERY WAS OUT OF THE INFUSION DEVICE FOR 2 HOURS AND A NEW ONE WAS INSERTED; STILL RECEIVING AN E7 ERROR MESSAGE. PT IS UNABLE TO RETRACT THE PISTON ROD BECAUSE OF THE ERROR. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARITY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVAL.

    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 11 YR INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN