BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2803136 · Received October 19, 2012

    Report

    Report Number
    2183996-2012-01624
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 15, 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
    BR
    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

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLIES WITH THE SPECIFICATIONS, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. (B)(4): DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE, MOISTURE MAY ENTER THE INSULIN PUMP AND DESTROY THE PUMP ELECTRONICS. THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY AND COMPLY WITH THE PRODUCT SPECIFICATIONS. ALSO THE ALARM FUNCTIONS WERE TESTED SUCCESSFULLY AND NO MALFUNCTION COULD BE OBSERVED DURING THE TECHNICAL INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PT HAD TONSILLITIS AND HYPERGLYCEMIA. HER ENDOCRINOLOGIST PRESCRIBED SEVEN DAYS OF ANTIBIOTICS AND CHANGED THE BASAL DOSE ON THE INFUSION DEVICE TO 0.3 UNITS OF INSULIN PER HOUR. FIFTEEN DAYS LATER THE PT WAS STILL EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS OVER 400 MG/DL. THE DOCTOR THINKS THE ELEVATED BLOOD GLUCOSE LEVELS ARE DUE TO AN INFECTION AND HE APPLIED BENZETACIL ANTIBIOTIC. TESTS DID NOT SHOW ANY INFECTION. THE PT THINKS HER INFUSION DEVICE IS FAILING TO KEEP HER BLOOD GLUCOSE LEVELS FROM BEING ELEVATED. THE PT EXPERIENCED NAUSEA AND DIZZINESS. ON (B)(6) 2012, HER BLOOD GLUCOSE LEVEL WAS 419 MG/DL IN THE MORNING, 495 MG/DL IN THE AFTERNOON, AND 480 MG/DL AT NIGHT. ON (B)(6) 2012, HER BLOOD GLUCOSE LEVEL WAS 467 MG/DL IN THE MORNING, 394 MG/DL IN THE AFTERNOON, AND 487 MG/DL AT NIGHT. TROUBLE SHOOTING WITH THE PT DID NOT IDENTIFY THE CAUSE OF THE ELEVATED BLOOD GLUCOSE LEVELS. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED 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 15 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES