BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4031494 · Received August 22, 2014

    Report

    Report Number
    2531779-2014-24228
    Event Type
    Injury
    Date Received
    August 22, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/02/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE PUMP¿S BLACK BOX REVEALED THE BASAL AND BOLUS HISTORIES CORRECTLY MATCHED THE TOTAL DAILY DOSE HISTORY. A REPLACE CARTRIDGE ALARM WAS OBSERVED WITH 9 SUBSEQUENT LOSS OF PRIME ALARMS AND 1 REPLACE BATTERY ALARM FOLLOWING. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD HAD FAILED. UNRELATED TO THE COMPLAINT, A BATTERY COMPARTMENT CRACK WAS OBSERVED. THE RETURNED BATTERY CAP WAS ABLE TO PROPERLY SECURE TO THE PUMP. INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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 ALLEGED THE PATIENT¿S BLOOD GLUCOSE WAS ABOVE 600 MG/DL WITH LARGE KETONE LEVELS, ABDOMINAL PAIN, VOMITING, AND NAUSEA ON AN UNSPECIFIED DATE. IT WAS REPORTED THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT, THE PUMP SETTINGS WERE NOT RECENTLY ADJUSTED BY THE PATIENT¿S HEALTH CARE PROVIDER, AND THE PATIENT REMAINED ON THE PUMP. THE REPORTER NOTED THE PUMP¿S TIME AND DATE SETTING RESET TO DEFAULT WHEN THE BATTERY WAS REMOVED FROM LESS THAN 24 HOURS. THE USER MUST MANUALLY CONFIRM THE SETTINGS PRIOR TO USE OF THE DEVICE. THE PUMP DISPLAYS THE ¿VERIFY¿ SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE CONFIRMED ON THE ¿VERIFY¿ SCREEN. REPORTEDLY, THE PATIENT¿S DIABETIC MANAGEMENT ISSUES CONTRIBUTED THE ALLEGED HYPERGLYCEMIA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED HYPERGLYCEMIA WAS RELATED TO A USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508823 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening