BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2072979 · Received April 29, 2011

    Report

    Report Number
    2531779-2011-02993
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/13/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND HISTORY FOR EVENT ON (B)(4) 2011 HAVE BEEN OVERWRITTEN. REVIEW OF THE AVAILABLE BLACK BOX AND ALARM HISTORY SHOWS NO EAW¿S RELATED TO THE COMPLAINT. THE TOTAL DAILY DOSE (TDD) ADDS UP CORRECTLY AND REFLECTS THE USER PROGRAMMED BASAL RATE. PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. PUMP IS NOT DETECTING THE CORRECT FORCE AT 5 LBS. REMOVED COVER AND DISASSEMBLED PUMP; FORCE SENSOR RESISTANCE WAS OUT OF SPECIFICATIONS. NO EVIDENCE OF CONTAMINATION FOUND IN FORCE SENSOR HOUSING. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS TO ALLEGING THAT HE HAS HAD HIGH BLOOD GLUCOSE (BG) READINGS OFF AND ON SINCE STARTING THE PUMP BACK IN (B)(6) 2010. AT THE TIME OF THE CALL, THE PATIENT REPORTED A HIGH BG OF 549 MG/DL. THE PATIENT CLAIMED HE HAS NOT CHECKED FOR KETONES; HOWEVER, REPORTED WEIGHT LOSS IN ADDITION TO MENTIONING ALL OF HIS TEETH HAVE BEEN PULLED OUT. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED TAKING ANY NEW MEDICATIONS OR MAKING CHANGES TO ACTIVITY LEVEL. THE PATIENT CONFIRMED HE CHANGES SITE EVERY 2-3 DAYS AND THERE WERE NO SIGNS OF IRRITATION. CONFIRMED THERE WERE NO AIR BUBBLES OR SIGNS OF INSULIN LEAKING FROM CARTRIDGE AT THE TIME OF THE CALL. DURING REVIEW OF PUMP, CONFIRMED ALL SETTINGS WERE CORRECT AND STATED THERE WERE NO ALARMS IN PUMP HISTORY. BASAL RATE AND BOLUS DOSES FOR PAST 24 HOURS WERE EQUAL TO TOTAL DAILY DELIVERY (TDD) THAT APPEARED IN PUMP'S HISTORY. IT WAS NOTED THAT A 3 UNIT AIR BOLUS WAS DONE SUCCESSFULLY AT THE TIME OF THE CALL. THE PATIENT CLAIMED HE DOES NOT USE EZCARB AND EZBG OF PUMP. THE PATIENT STATED HE ADDS HIS CARBOHYDRATE AND BLOOD GLUCOSE AND DOES A "NORMAL" BOLUS. THE PATIENT CONFIRMED THE INSULIN IN USE WAS CLEAR AND WITHIN ITS EXPIRATION DATE; HOWEVER, REPORTED THAT HE FILLS THE CARTRIDGE WITH COLD/REFRIGERATED INSULIN. THE PATIENT WAS ADVISED TO ONLY USE ROOM-TEMPERATURE INSULIN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OBTAINED A BLOOD GLUCOSE READING GREATER THAN 500 MG/DL WHILE THE SUBJECT DEVICE WAS IN USE.

    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 56 YR Life Threatening