BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2896355 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01890
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    August 1, 2012
    Report Date
    March 26, 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

    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

    PRODUCT WAS 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 PT HAD EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS SINCE (B)(6) 2012. RECENTLY WHILE FILLING THE CATHETER FILLING, THE PT'S PARENTS NOTICED NO INSULIN WAS COMING OUT OF THE INFUSION TUBING BUT WHEN THEY "KNOCKED" THE INFUSION DEVICE INSULIN BEGAN TO COME OUT OF THE INSULIN TUBING. THE PT'S PARENTS STATED THE SAME THING HAPPENS WHEN THEY PROGRAM A BOLUS. THEY THINK THE INFUSION DEVICE IS DELIVERING INSULIN INACCURATELY OR THE PISTON ROD IS NOT FUNCTIONING PROPERLY. THE PT 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 5 YR RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP