BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3092118 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05848
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    THE REPORTER (PATIENT'S MOTHER) CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) IN THE 400 MG/DL RANGE FOR SEVERAL DAYS AND POSSIBLY SINCE (B)(6) 2012. THE PATIENT HAD THE PUMP SETTINGS ADJUSTED IN (B)(6) 2012 AND THE BG BECAME STABLE BUT THEN BEGAN TO ELEVATE AGAIN, AVERAGING 200 MG/DL. THE REPORTER STATED ON (B)(6) 2013, THE PATIENT'S BG BECAME ELEVATED AND TROUBLESHOOTING THE EQUIPMENT DID NOT ALLEVIATE THE BG ELEVATION. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM FOR ELEVATED BG WITH LARGE KETONES, CHEST PAIN, SHORTNESS OF BREATH AND NAUSEA. THE PATIENT WAS TREATED WITH IV INSULIN AND FLUIDS AND THE BG RESPONDED BY COMING DOWN TO 210 MG/DL. THE PATIENT WAS DISCHARGED TO HOME USING THE INSULIN PUMP ONLY FOR BASAL DELIVERY OF INSULIN AND WAS GIVING MANUAL INJECTIONS FOR BOLUSES. THAT SAME NIGHT, THE PATIENT WAS REPORTEDLY GIVEN AN INSULIN BOLUS FOR ELEVATED BG BY MANUAL INJECTION (UNSPECIFIED AMOUNT) AND THE BG RESPONDED BY LOWERING TO 250 MG/DL, BUT ELEVATED AGAIN TO 380 MG/DL AFTER THE BOLUS WORE OFF TWO HOURS LATER. THE PATIENT'S HEALTHCARE PROVIDER (HCP) ADVISED THE PATIENT DISCONTINUE INSULIN PUMP THERAPY BECAUSE HE FEELS THE PUMP IS NOT FUNCTIONING PROPERLY. THE PATIENT WAS ON A BACKUP PLAN AT THE TIME OF THE CALL TO ANIMAS AND THE PATIENT'S BG WAS REPORTEDLY 173 MG/DL. TROUBLESHOOTING PERFORMED BY ANIMAS CUSTOMER TECHNICAL SUPPORT DURING THE CALL FAILED TO REVEAL A REASON FOR THE ELEVATED BG. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD ELEVATED BG ON INSULIN PUMP THERAPY REQUIRING MEDICAL TREATMENT. HCP ALLEGED PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193847 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L| R