BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2073073 · Received April 29, 2011

    Report

    Report Number
    2531779-2011-02994
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP BOOTS TO VERIFY SCREEN WITH AUDITORY AND VIBRATORY ALARMS. THE DATE AND TIME WERE SET TO CURRENT DATE AND TIME. AN "EZPRIME" OPERATION WAS PERFORMED WITH NO DIFFICULTIES. THERE WERE NO ALARMS RELATED TO THE COMPLAINT IN THE ALARM HISTORY; REVIEW OF THE TDD SHOWS 80.0U TOTAL ON (B)(4) 2011. A REVIEW OF THE PUMP HISTORY CONFIRMS TIME DEFAULTS TO FACTORY SETTINGS AFTER A REBOOT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO PROBLEMS. THE PUMP WAS DISASSEMBLED AND OBSERVED LEAKING BACKUP BATTERY AT BT1 LOCATION.

    Additional Manufacturer Narrative · 1

    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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT 80 UNITS OF INSULIN WAS DELIVERED ON (B)(6) 2011. THE PUMP HISTORY INDICATED THAT THE TIME AND DATE WERE INADVERTENTLY SET INCORRECTLY AFTER A BATTERY CHANGE, RESULTING IN THE PUMP RECORDING BASAL DELIVERY FOR 45 HOURS ON (B)(6) 2011. THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY CONTINUED ONCE THE DATE AND TIME WERE CORRECTLY SET. DURING INVESTIGATION, THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO INSULIN DELIVERY ISSUES. AN EZPRIME OPERATION WAS PERFORMED WITH NO ISSUES. THERE WERE NO INSULIN DELIVERY DEFECTS FOUND ON INVESTIGATION. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO THE BASAL/BOLUS PROGRAMMING ISSUE. REPORTEDLY, THE ANIMAS IS GIVING AN ALARM INDICATING HER MAXIMUM INSULIN INTAKE OF 80 UNITS HAS BEEN REACHED EVEN THOUGH THE PATIENT HAS NOT TAKEN ANY INSULIN ON THE DAY OF CONCERN. IN ADDITION, THE DATE AND TIME HAS TO BE RESET EACH TIME THE BATTERY IS CHANGED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR