BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2832324 · Received November 14, 2012

    Report

    Report Number
    2531779-2012-13605
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 SUBMITTED: (B)(4) 2012 - CORRECTION TO ADDITIONAL MANUFACTURER'S NARRATIVE STATEMENT: THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DELIVERY ISSUES.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 12/24/2012 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 2 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S FATHER CONTACTED ANIMAS CONCERNED ABOUT ELEVATED BLOOD GLUCOSE (BG) LEVELS THE PATIENT HAD BEEN GETTING ON (B)(6) 2012. THE REPORTER STATED THE PATIENT'S BG HAD GONE UP TO 409 MG/DL THE EVENING PRIOR. THE REPORTER DENIED THAT THE PATIENT DEVELOPED ANY SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA WITH THE ELEVATED BG READING(S). WHEN THEY REVIEWED BOLUS HISTORY ON THE PUMP IT WAS SHOWING 0.00 OF 0.00 COMPLETED ON (B)(6) 2012. THE PATIENT'S FATHER CLAIMED THE PATIENT PROGRAMMED IN THE BOLUSES AS HE AND HIS WIFE WATCHED HIM DO IT PROPERLY. THE PATIENT'S REPORTED BG READING DOES NOT MEET ANIMAS CRITERIA OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PUMP ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    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 11 YR