BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2896341 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01889
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Report Date
    March 27, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT RECEIVED ON (B)(4) 2013. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS HAVE BEEN ELEVATED AS HIGH AS 500 MG/DL SINCE (B)(6) 2012. THE PATIENT HAS TRIED TO CORRECT THE ELEVATED BLOOD GLUCOSE LEVELS WITH THE INFUSION DEVICE, BUT EVEN AFTER CHANGING THE ACCESSORIES IT WAS UNSUCCESSFUL. THE PATIENT AND HER DIABETIC SPECIALIST THINK THE INFUSION DEVICE IS DELIVERING TOO LOW AN AMOUNT OF INSULIN. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    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 6 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP