BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2915331 · Received December 28, 2012

    Report

    Report Number
    2183996-2012-02077
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 13, 2012
    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 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 PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSIS TEST AND MEET THE SPECIFICATION. ALL ALARM FUNCTIONS WERE TESTED SUCCESSFUL AND NO MALFUNCTION COULD BE OBSERVED DURING THE IU INVESTIGATION. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PATIENT¿S MOTHER REPORTED PATIENT HAS BEEN EXPERIENCING VERY ELEVATED BLOOD GLUCOSE LEVEL FOR THE LAST 2 WEEKS. MOTHER STATED SHE CALLED THE DOCTOR TO SEE IF THE CONCERN WAS WITH THE PATIENT¿S BASAL RATE BUT EVERYTHING SEEMED ALRIGHT. MOTHER REPORTED THEY ALSO TRIED CHANGING THE INFUSION SET SEVERAL TIMES AND THE CONCERN PERSISTED. MOTHER STATED A COLLEAGUE SUGGEST THEY USE THE BACK-UP INFUSION DEVICE AND NOW THE PATIENT¿S BLOOD GLUCOSE LEVEL HAS RETURNED TO NORMAL. PATIENT¿S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. MOTHER REPORTED THE INFUSION DEVICE DID NOT DISPLAY ANY ALARM OR ERROR MESSAGE. MOTHER STATED THE CONCERN WAS SOLVED BY CHANGING TO THE BACKUP INFUSION DEVICE. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES