BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2913483 · Received December 21, 2012

    Report

    Report Number
    2183996-2012-02008
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 19, 2012
    Report Date
    March 11, 2013
    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
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. THE BATTERY SPRING IS BROKEN, AND THE REASON IS UNKNOWN. DUE TO THIS, THE CONTACT TO THE POWER SOURCE IS INTERRUPTED AND THE INSULIN PUMP CANNOT BE STARTED. THE WARNINGS W2 (BATTERY LOW) AND E2 (BATTERY DEPLETED) WERE FOUND IN THE PUMP HISTORY. THE MENTIONED W2/E2 WARNINGS ARE NOT A MALFUNCTION OF THE PUMP. THE ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. ALL ERRORS AND ALERTS WERE TRIGGERED CORRECTLY BY THE PUMP.

    Additional Manufacturer Narrative · 1

    THE 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

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PT¿S INFUSION DEVICE DISPLAYED E2 (BATTERY EMPTY) WITHOUT FIRST DISPLAYING A2 (BATTERY LOW). THE PT REPLACED THE BATTERY, BUT THE DEVICE AGAIN DISPLAYED E2 WITHOUT FIRST DISPLAYING A2. THE PT STATED THAT THE DEVICE TURNED OFF SUDDENLY. THE PT HAS EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT 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 INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP