BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3030197 · Received April 2, 2013

    Report

    Report Number
    2183996-2013-00551
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT 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 BLUETOOTH FUNCTION OF THE PUMP WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. HISTORY LIST: ALL BOLUSES WERE PROGRAMMED AND DELIVERED THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED HIS BLOOD GLUCOSE LEVEL WAS 434 MG/DL AT THE BEGINNING OF THE CALL. PATIENT STATED THE GLUCOSE MONITORING DEVICE GAVE A BOLUS RECOMMENDATION. PATIENT REPORTED WHEN HE ATTEMPTED TO DELIVER THE BOLUS WITH THE METER, THE METER DISPLAYED BOLUS DELIVERY UNAVAILABLE. PATIENT STATED HE DID NOT MANUALLY PLACE THE INFUSION DEVICE INTO STOP MODE. VERIFIED TIME WAS CORRECT. REVIEWED ALARM HISTORY. DURING TROUBLESHOOTING THERE WERE NO RECENT ALARMS EXPLAINING WHY THE INFUSION DEVICE WAS IN STOP MODE. HAD PATIENT PLACE THE INFUSION DEVICE INTO RUN MODE. PATIENT REPORTED HE TESTED HIS BLOOD GLUCOSE LEVEL AGAIN AT 453 MG/DL AND THEN DELIVERED A BOLUS OF 17 UNITS OF INSULIN SUCCESSFULLY USING THE GLUCOSE MONITORING DEVICE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134316 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR MULTIVITAMIN| NADOLOL| SPIRONOLACTONE| ZINC SULFATE| RIFAMPIN| URSODIOL| HUMALOG INSULIN| ZOLDIDEM TARTRATE| VITAMIN C| CITALOTRAM HRB