BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3951979 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21001
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS NOT EXPECTED TO BE RETURNED AT THE TIME OF THIS REPORT. IF AT A LATER DATE THE PUMP IS RETURNED, AN EVALUATION SHALL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX SHOWS EVIDENCE OF TWO CALL SERVICE 088 ALARMS. AN EZPRIME AND 24 HOUR DURATION TEST WERE SUCCESSFULLY COMPLETED WITH NO CALL SERVICE ALARMS BEING DUPLICATED. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATE. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THERE WAS EVIDENCE OF INTERNAL MOISTURE OBSERVED ON THE PRINTED CIRCUIT BOARD AND THE INTERNAL COMPONENTS. THE BATTERY COMPARTMENT WAS CRACKED AT THE CASE SEAL. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP SO A TEST BATTERY CAP WAS USED FOR INVESTIGATION. THE COMPLAINT WAS CONFIRMED IN THE PUMP HISTORY BUT NOT DUPLICATED DURING TESTING. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A SEVERE HYPERGLYCEMIC EVENT ON THAT SAME DAY. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE LEVEL OF 450 MG/DL WITH SYMPTOMS OF KETONES AND NAUSEA. THE REPORTER STATED THAT THE PUMP WAS PRESENTING WITH A CALL SERVICE ALARM AND THAT THE ALARM WAS NOT CLEARED UNTIL SEVERAL HOURS LATER, RESULTING IN THE PATIENT BEING WITHOUT INSULIN DURING THAT TIMEFRAME. THE PUMP WAS NOT REQUIRED FOR RETURN BY THE REPORTER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A SEVERE HYPERGLYCEMIC EVENT RELATING TO USE ERROR OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431566 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening