BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2850151 · Received November 21, 2012

    Report

    Report Number
    2183996-2012-01784
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 15, 2012
    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
    IT
    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 ALARM FUNCTIONS OF THE PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PT HAD BEEN HAVING TROUBLE WITH THE INSULIN DELIVERY FROM HIS INFUSION DEVICE FOR THE PAST TWO WEEKS. ON (B)(6) 2012, HIS BLOOD GLUCOSE LEVEL WAS ELEVATED TO 500 MG/DL. HE PROGRAMMED A BOLUS OF 9 UNITS OF INSULIN AND THE INFUSION DEVICE APPEARED TO DELIVER THE INSULIN PROPERLY, BUT HIS BLOOD GLUCOSE LEVEL DID NOT DECREASE. HE CHANGED THE INFUSION SET AND THE ISSUE SEEMED TO BE RESOLVED. A COUPLE OF DAYS FOLLOWING THAT, HE REPLACED JUST THE INFUSION HEADSET AND AGAIN EVERYTHING APPEARED TO BE WORKING PROPERLY. ON (B)(6) 2012, HE NOTICED HIS BLOOD GLUCOSE LEVEL WAS ELEVATED AND IT AGAIN REACHED 500 MG/DL. HE BOLUSED 9 UNITS OF INSULIN. THE PT THINKS THE INFUSION DEVICE SHOULD BE DISPLAYING AN ALERT OR ERROR THAT IS NOT BEING DISPLAYED. HIS NORMAL BLOOD GLUCOSE LEVEL IS 150 MG/DL. 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 EVAL.

    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 INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN