BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2760689 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11281
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE USER SETTINGS INDICATED THE MAX TOTAL DAILY DOSE WAS SET TO 40 UNITS, WITH THE MAX 2 BEING SET AT 12 UNITS. ON (B)(4) 2012 THE PUMP EMITTED A "NO DELIVERY, EXCEEDS TDD" ALARM, AS THE TOTAL DAILY INSULIN DELIVERY TOTALS FOR THOSE DAYS HAD REACHED THE MAXIMUM DAILY LIMIT OF 40 UNITS AS SET BY THE USER. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD BUTTONS WERE TESTED AND WERE FOUND TO BE RESPONDING APPROPRIATELY; THERE WERE NO HYPERSENSITIVE KEYPAD BUTTONS OBSERVED. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS (ANM) ON BEHALF OF HIS DAUGHTER (THE PATIENT) AND REPORTED AN ELEVATED BLOOD GLUCOSE (BG) EVENT. THE REPORTER INDICATED THAT THE PUMP HAD BEEN GIVING FREQUENT EXCEEDED MAX TDD ALARMS. DUE TO THE ALLEGED ISSUE, THE REPORTER ADMITTED THAT THEY HAD BEING DECREASING THE BOLUS AMOUNTS TO PREVENT THE ALARM FROM RECURRING. DURING THE TIME OF CONCERN, THE REPORTER CLAIMED THAT THE PATIENT'S BG LEVEL HAD INCREASED AT ONE POINT TO '532 MG/DL' WITH NO SYMPTOMS. THE REPORTER DID NOT REPORT ANY MEDICAL INTERVENTION IN RELATION TO THE HIGH BG LEVELS. THE PUMP'S DATE AND TIME WERE CONFIRMED AS BEING CORRECT. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING/TRAINING. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED AN ELEVATED BG LEVEL SUGGESTIVE OF SEVERE HYPERGLYCEMIA. HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO POSSIBLE USE-ERROR. THE ALLEGED PRODUCT ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT SINCE THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON.

    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 8 YR Life Threatening