BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2890527 · Received December 31, 2012

    Report

    Report Number
    2531779-2012-15242
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PUMP BLACK BOX SHOWED THAT THE PUMP WAS TURNED OFF FROM (B)(4) 2012 UNTIL (B)(4) 2012. NO BOLUSES OR BASAL DELIVERIES WERE RECORDED DURING THIS TIME. THE KEYPAD BUTTONS WERE TESTED AND CONFIRMED THAT THE BUTTONS WERE RESPONDING APPROPRIATELY AND THERE WERE NO HYPERSENSITIVE BUTTONS FOUND. AN AUDIO BOLUS AND A NORMAL BOLUS WERE PERFORMED AND WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR OTHER ISSUES OCCURRING. THE COMPLAINT WAS UNABLE TO BE DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE BATTERY CAP WAS OBSERVED TO BE STUCK TO THE PUMP AND THE BATTERY CAP COIN SLOT WAS OBSERVED TO BE DAMAGED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012, ALLEGING THAT HE HAD EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) BETWEEN 300-400 MG/DL FOR THE PAST WEEK WITH NO SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THIS ELEVATION OF BG DOES NOT MEET THE ANIMAS CRITERIA OF A SERIOUS ADVERSE EVENT AND NOT CONSIDERED TO BE REPORTABLE. THE PATIENT STATED THAT HIS HEALTHCARE PROVIDER (HCP) ADVISED HIM TO DISCONTINUE USE OF THE INSULIN PUMP THERAPY DUE TO THE CONCERNS REGARDING THE ELEVATED BG. THE DAY OF THE CALL TO ANIMAS, THE PATIENT WAS BEGUN ON INSULIN DELIVERY VIA INSULIN PEN FOR BOLUS DELIVERY. REVIEW OF THE INSULIN PUMP BY ANIMAS CUSTOMER TECHNICAL SUPPORT REVEALED THAT THERE WAS NO RECORDED HISTORY IN THE PUMP FOR USE BETWEEN (B)(6) 2012. THIS TIME PERIOD WAS CONFIRMED AS THE TIME PERIOD IN WHICH THE PATIENT ALLEGED THE ELEVATED BLOOD GLUCOSE. THE PATIENT WAS ADAMANT THAT HE WAS WEARING THE PUMP DURING THIS PERIOD OF TIME, HOWEVER, THE PUMP SHOWED NO RECORD OF BEING ON. THE PATIENT DENIED ANY RECENT TRAUMA TO THE PUMP OR EVIDENCE OF MOISTURE IN THE PUMP. THE PATIENT REMAINED ON THE BACKUP PLAN AT THE CONCLUSION OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED THE PUMP WAS BEING USED DURING A TIME PERIOD THAT THE PUMP HISTORY SHOWED THE PUMP WAS NOT IN OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR