BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242986 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11745
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/25/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX REVEALED SEVERAL POWER EVENTS RELATED TO DISCHARGED BATTERIES. THERE WAS NO EVIDENCE OF SUDDEN VOLTAGE DROPS IN THE PUMP HISTORY. THE TOTAL DAILY DOSE HISTORY INDICATED THAT THE TOTAL DAILY DOSE HISTORY ADDED UP CORRECTLY AND CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. UPON EXAMINATION, THE PUMP BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE PUMP POWERED ON TO THE VERIFY SCREEN AND WAS EXERCISED FOR 24 HOURS WITHOUT POWER LOSS OR OVER HEATING OCCURRING. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED ON THE PUMP AND CONFIRMED THAT THE PUMP WAS DELIVERY WITHIN SPECIFICATIONS. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP CASE WAS OPENED AND NO EVIDENCE OF INTERNAL MOISTURE DAMAGE WAS FOUND AND THERE WAS NO INTERMITTENT CONDITIONS FOUND DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 CONTACTED ANIMAS ON (B)(6) 2013 STATING THAT THE PATIENT HAD A BLOOD GLUCOSE OF 30 MMOL/L WITH NAUSEA AND HEADACHE. THE REPORTER STATED THAT THE PATIENT WENT SWIMMING WITH THE PUMP AND WHEN THE PATIENT GOT OUT OF THE WATER THE PUMP WAS HOT TO THE TOUCH. THE REPORTER STATED THAT THE PUMP WAS REMOVED WATER AND CORROSION WERE FOUND ON THE BATTERY. THE REPORTER STATED THAT THE BATTERY WAS CHANGED AND THE PUMP TEMPERATURE RETURNED TO NORMAL BUT THE PATIENT¿S BLOOD GLUCOSE LEVELS HAD BEEN ELEVATED TO 30 MMOL/L SINCE THE PUMP MOISTURE EVENT. THE REPORTER CONFIRMED NO ISSUES WITH PUMP POWER AND INDICATED THAT CHANGING THE SITE DID NOT RESOLVE THE ELEVATED BLOOD GLUCOSE LEVELS. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PATIENT¿S HYPERGLYCEMIA AFTER THE PUMP TEMPERATURE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343002 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR