BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3930442 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19804
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/18/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE PUMP¿S HISTORY FOUND NO ALARMS OR ISSUES RELATED TO THE COMPLAINT. THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2014. BASAL AND BOLUS DELIVERIES IN THE HISTORY MATCHED THE TOTAL DAILY DOSE HISTORY. THE KEYPAD BUTTONS AND BOLUS BUTTON WERE APPROPRIATELY RESPONSIVE. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP SUCCESSFULLY COMPLETED A DELIVERY ACCURACY TEST WITHOUT ISSUE. UNRELATED TO THE COMPLAINT, A BATTERY COMPARTMENT CRACK WAS DISCOVERED DURING EVALUATION. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST CAP WAS USED FOR INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT¿S BLOOD GLUCOSE WAS ABOVE 250 MG/DL AND BELOW 500 MG/DL WITH EXTREME DROWSINESS, DIFFICULTY WAKING UP, CONFUSION, DIZZINESS, LIGHTHEADEDNESS, AND POLYDYPSIA. THE REPORTED NOTED THE PATIENT WAS TREATED BY THEIR HEALTH CARE PROVIDER WITH INSULIN FROM THE PUMP AND THE PATIENT REMAINED ON THE PUMP AFTER THE REPORTED EVENT. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THE PUMP¿S RECORDED BOLUS HISTORY AND BOLUS TOTALS IN THE TOTAL DAILY DOSE HISTORY WERE DISCREPANT; THE BASAL HISTORY AND BASAL TOTALS IN THE TOTAL DAILY DOSE HISTORY CORRELATED APPROPRIATELY. ANIMAS CUSTOMER TECHNICAL SERVICE DETERMINED THAT THE PATIENT¿S REPORTED WEIGHT GAIN CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE REPORTER NOTED THE PATIENT¿S HEALTH CARE PROVIDER MADE RECENT CHANGES TO THE PUMP¿S BOLUS RATE AND BOLUS SETTINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED HYPERGLYCEMIA WAS ASSOCIATED WITH AN ALLEGED BOLUS DELIVERY ISSUE OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406347 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R