BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2861017 · Received December 3, 2012

    Report

    Report Number
    2183996-2012-01873
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. 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. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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 EXPERIENCING NAUSEA, VOMITING AND ELEVATED BLOOD GLUCOSE LEVEL OF APPROXIMATELY 600 MG/DL. PATIENT REPORTED RECEIVING STATIONARY TREATMENT FROM (B)(6) 2012. PATIENT REPORTED BEING IN THE ICU FROM (B)(6) 2012 AND THEN IN THE REGULAR CARE UNIT FROM (B)(6) 2012. PATIENT REPORTED TAKING CORRECTION VIA THE PEN. TREATMENT RECEIVED IN THE HOSPITAL WAS NOT PROVIDED. PATIENT REPORTED BLOOD GLUCOSE LEVEL IS OKAY AT THIS TIME. PATIENT'S NORMAL BLOOD LEVEL WAS NOT PROVIDED. PATIENT REPORTED RECEIVING ELEVATED BLOOD GLUCOSE READING OF 333 MG/DL ON (B)(6) 2012. PATIENT REPORTED TAKING CORRECTION VIA THE INFUSION DEVICE AND PERFORMED SEVERAL ACCESSORY CHANGES WITH NO SUCCESS. PATIENT DISCARDED THE ALLEGED ACCESSORIES. PATIENT REPORTED TAKING CORRECTION VIA THE PEN. PATIENT STATED NO HEALTH PROBLEMS. PATIENT THINKS THE INFUSION DEVICE DELIVERY IS INACCURATE AND DELVERS TOO LOW INSULIN AMOUNT. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYTEMS INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES