BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2943244 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00047
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 8, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. PRODUCTION DATA WAS REVIEWED AND COMPLY WITH SPECIFICATIONS. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED. NO PRODUCT WAS RETURNED.

    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 INSULIN CARTRIDGE OF THE INFUSION DEVICE HAS LEAKAGE. PATIENT STATED SHE OFTEN HAS ELEVATED BLOOD GLUCOSE LEVEL. ACTUAL BLOOD GLUCOSE READING WAS NOT PROVIDED. TREATMENT RECEIVED WAS NOT PROVIDED. REQUEST FOR ASSISTANCE WAS SUBMITTED AND EDUCATOR WAS SENT TO THE PATIENT'S HOME. 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
    28981 ACCU-CHEK SPIRIT CARTRIDGE LZG ROCHE HEALTH SOLUTIONS, INC. 00700006871 32343261

    Patients

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