BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3020679 · Received March 26, 2013

    Report

    Report Number
    2183996-2013-00506
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 8, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT DESCRIBING AN OCCLUDED INFUSION SET CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER. RESULT INFUSION SET: THE TWO USED RETURNED TRANSFER SETS WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. AN OCCLUSION WITH INSULIN WAS FOUND BEHIND THE CONNECTOR NEEDLE OF BOTH TRANSFER SETS. THE MANUFACTURER TESTS ALL PRODUCTS DURING PRODUCTION FOR LEAK AND FLOW. THERE IS NO INDICATION THAT A NONSPECIFIC PRODUCT HAS BEEN DELIVERED TO ANY CUSTOMER. PUMP: 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. E4 WERE FOUND IN THE HISTORY. THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY. HISTORY LIST: NO HISTORY LIST IS NECESSARY. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SINCE (B)(6) 2013 SHE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AND THE INFUSION DEVICE OFTEN DISPLAYS AN E4 (OCCLUSION) ERROR MESSAGE. PATIENT STATED SHE USED AN ALTERNATIVE PUNCTURE PLACE AND ACCESSORIES WITH A DIFFERENT LOT NUMBER; NO E4 BUT HER BLOOD GLUCOSE LEVEL IS TOO HIGH, MORE THAN 400 MG/DL. PATIENT REPORTED SHE TOOK CORRECTION VIA THE INFUSION DEVICE; NO SUCCESS. PATIENT STATED SHE THINKS THE INFUSION DEVICE DELIVERY IS TOO LOW AMOUNT OF INSULIN. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. 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
    124382 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR