BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2233185 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06447
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. A REVIEW OF THE BOLUS HISTORY CONFIRMED A 21.6 UNIT BOLUS ON (B)(6) 2011 AT 4:27AM. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES OCCURRING; NO UNPROGRAMMED BOLUSES OCCURRED DURING TESTING. A NORMAL BOLUS AND AN AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND ACCURATELY RECORDED IN THE PUMP HISTORY. EVALUATION CONFIRMED THAT THE KEYPAD IS PEELING NEAR THE OK KEYPAD BUTTON. A DAMAGED KEYPAD WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED KEYPAD SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. INVESTIGATION REVEALED THAT ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY TO BUTTON PRESSES AND THERE WERE NO HYPERSENSITIVE OR DEFECTIVE BUTTON CONTACTS FOUND.

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS 30MG/DL WITH LOSS OF CONSCIOUSNESS ON (B)(6) 2011. A FAMILY MEMBER CALLED 911 AND PARAMEDICS TREATED THE PATIENT WITH INTRAVENOUS GLUCOSE AT HOME BETWEEN 6AM AND 7AM. HIS BG RESOLVED TO 220MG/DL A SHORT TIME LATER. CUSTOMER SUPPORT REVIEWED THE PATIENT'S BOLUS HISTORY AND DISCOVERED A BOLUS OF 21.6 UNITS WAS PROGRAMMED AND DELIVERED AT 4:27AM; THE BOLUS WAS RECORDED AS A NORMAL BOLUS (NO BG OR CARBOHYDRATES USED FOR CALCULATION). THE PATIENT DENIED THAT HE PROGRAMMED OR DELIVERED THIS BOLUS. HE REPORTED THAT THE KEYPAD BEGAN TO PEEL BELOW THE OKAY BUTTON ABOUT ONE WEEK PRIOR TO THE EVENT; HE DENIED ANY ISSUES WITH THE RESPONSIVENESS OF THE BUTTONS. THE COMPLAINT IS BEING REPORTED BECAUSE THE BG EXCURSION WAS RELATED TO THE USE OF AN INSULIN PUMP, MALFUNCTION OR MISUSE.

    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 50 YR Life Threatening