BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DACCU-CHEK SPIRIT COMBO

    MDR report key: 2943254 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00046
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 7, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. ERRORS E7002 WERE FOUND IN THE HISTORY, AND THE VIBRATOR MOTOR DOES NOT FUNCTION. AN INTERNAL DEFECT OF THE VIBRATOR LED TO THE PROBLEM. TEST AND INSPECTION OF THE RETURNED COMPLAINT DEVICE IDENTIFIED A DEFECTIVE COMPONENT. THIS COMPONENT IS INTENDED TO PROVIDE FEEDBACK ABOUT DEVICE ACTIVITY TO THE USER BY VIBRATION. THE DEVICE ALSO HAS AN AUDITORY ALERT SYSTEM FOR THE SAME FUNCTION. THE ESTABLISHED PRODUCT AND PROCESS RISK DOCUMENTS INCLUDE THE POTENTIAL FOR THIS FAILURE TO OCCUR IN THE MARKET.

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED, THE INFUSION DEVICE DISPLAYS AN E6 (MECHANICAL ERROR) MESSAGE AND AN E7 (ELECTRONIC ERROR) MESSAGE. PATIENT STATED AFTER RE-START, THE INFUSION DEVICE DISPLAYS E7 AGAIN. PATIENT REPORTED NO WATER CONTACT, NO EXTREME TEMPERATURE CHANGE, INFUSION DEVICE DIDN'T DROP AND NO ELECTROMAGNETIC FIELDS. ON (B)(6) 2013 UPON RECEIPT OF THE INFUSION DEVICE, PATIENT REPORTED VIA LETTER THAT THE VIBRATOR WAS DEFECTIVE AFTER THE E7 MESSAGE. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28826 DACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR ACCESSORIES| INSULIN INFUSION PUMP| DATE OF THERAPY: UNK| INSULIN