BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO CARTRIDGE

    MDR report key: 2932098 · Received January 18, 2013

    Report

    Report Number
    2183996-2013-00057
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 9, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED; THE PRODUCT MEETS THE SPECIFICATIONS 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 ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED WITHIN THE ALARM FUNCTION 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 BATTERY COVER AND ADAPTER PASSED THE OPTICAL INSPECTION.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INSULIN CARTRIDGE OF THE INFUSION DEVICE IS BROKEN. PATIENT STATED THERE WAS A LEAK DURING USE. PATIENT REPORTED DIDN'T NOTICE THE LEAKAGE. PATIENT STATED HER BLOOD GLUCOSE LEVEL WENT UP TO 26.0 MMOL/L (468 MG/DL) AND THEN SHE CHECK THE INFUSION DEVICE AND SAW THAT THE INSULIN CARTRIDGE WAS DEFECTIVE. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28629 ACCU-CHEK SPIRIT COMBO CARTRIDGE LZG ROCHE HEALTH SOLUTIONS INC. 00700006871 2FO38A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES