BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3082043 · Received April 29, 2013

    Report

    Report Number
    2183996-2013-00751
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 9, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSIS TEST AND MEET THE SPECIFICATION. ALL ALARM FUNCTIONS WERE TESTED SUCCESSFUL AND NO MALFUNCTION COULD BE OBSERVED DURING THE TECHNICAL INVESTIGATION. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. HISTORY LIST: NOTHING UNUSUAL WAS FOUND IN THE HISTORY LIST. ADAPTER: THE ADAPTER PASSED THE OPTICAL INSPECTION. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED EXPERIENCING CONTINUED ELEVATED BLOOD GLUCOSE LEVELS. PATIENT STATED IT TOOK 75 UNITS OF INSULIN TO PRIME NEW INFUSION SET TUBING AND THE INFUSION DEVICE NEVER TAKES THAT LONG TO PRIME. PATIENT IS FRUSTRATED. PATIENT REPORTED SHE IS A BRITTLE DIABETIC. PATIENT STATED HER ELEVATED BLOOD GLUCOSE LEVEL IS 423 MG/DL; WAS NOT FEELING ANY SYMPTOMS. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 150 MG/DL TYPICALLY. PATIENT REPORTED THERE WAS AN AIR BUBBLE IN THE INFUSION SET TUBING SO THE INSULIN WAS NOT BEING RECEIVED. PATIENT STATED SHE REMOVED THE LINE AND PUT A NEW LINE ON; NEEDS ASSISTANCE PRIMING THROUGH THE INFUSION SET TUBING. PATIENT REPORTED HAVING A RESPIRATORY INFECTION, MAYBE LIKE THE FLU BUT IS NOT TAKING ANY MEDICATION FOR IT; COULD BE ALLERGIES AND POLLEN FOR RIGHT NOW. PATIENT STATED SHE IS UNSURE ABOUT WHETHER SHE IS USING THE INFUSION DEVICE PROPERLY AT THIS TIME AND REQUESTED A TRAINER TO COME OUT. PATIENT REPORTED SHE WENT OUTSIDE TO DO YARD WORK AND WHEN SHE CAME IN SHE CHECKED HER BLOOD GLUCOSE LEVEL AND IT WAS 423 MG/DL. PATIENT STATED SHE TOOK 3.5 UNITS OF INSULIN TO CORRECT THE ELEVATED BLOOD GLUCOSE READING. PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS FOR A FEW DAYS; SINCE (B)(6) 2013 WITH LEVELS RANGING FROM 63 -349 MG/DL; WAS ABLE TO TAKE CORRECTION ON HER OWN. PATIENT STATED HER BASAL RATE HAS BEEN CHANGED A LOT THROUGH THE DOCTOR LATELY. ASSISTED PATIENT'S HUSBAND IN SETTING UP THE BACKUP INFUSION DEVICE. PATIENT'S HUSBAND REPORTED THERE IS A SMALL AIR BUBBLE IN THE CARTRIDGE; WAS PRIMED THROUGH SUCCESSFULLY. PATIENT WAS ABLE TO CONNECT TO THE HEAD SET AND START THE INFUSION DEVICE INTO RUN MODE. ON FOLLOW UP CALL ON (B)(6) 2013 PATIENT REPORTED THAT SINCE BEING ON THE BACKUP INFUSION DEVICE SHE HAS BEEN GETTING UP IN THE MORNING WITH LOW BLOOD GLUCOSE READINGS OF 50'S - 60'S MG/DL. PATIENT STATED SHE IS GOING TO MAKE AN ADJUSTMENT TO HER BASAL RATES. PATIENT REPORTED SHE BELIEVES THE BASAL RATE MAY NOT BE MATCHING WITH NEEDS. PATIENT STATED SHE IS NOT HAVING ANY PROBLEMS THAT SHE DOES NOT UNDERSTAND WITH THE BACKUP INFUSION DEVICE. PATIENT REPORTED SHE KNOWS THE LOW BLOOD GLUCOSE LEVELS IN THE MORNING IS BECAUSE OF MISMATCHED BASAL RATES. PATIENT STATED THAT ON THE PRIMARY INFUSION DEVICE SHE FELT THAT THE BASAL RATE WAS RUNNING AND SHE WAS RECEIVING INSULIN EVERY HOUR BUT WHEN IT CAME TO THE BOLUS, IT NEVER GOES THROUGH PROPERLY. PATIENT REPORTED SHE CHANGED THE TUBING MANY TIMES. PATIENT STATED THE INFUSION DEVICE DID NOT PROVIDE CORRECT INSULIN FOR NEEDS ON BOLUS CORRECTIONS AND THIS CAUSED HER ELEVATED BLOOD GLUCOSE READINGS. 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 AND ADAPTER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184956 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR ACCUCHEK SPIRIT BACK UP PUMP| NOVALOG