BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2161402 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04923
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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: A STRIPPED BATTERY CAP WAS RETURNED WITH THE PUMP; THE PUMP WILL NOT PROPERLY POWER UP SO A TEST CAP WAS USED FOR TESTING PURPOSES. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT EVERY SIX MONTHS AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. THE PUMP BOOTS UP PROPERLY TO THE VERIFY SCREEN WITH THE TEST CAP. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED, WHICH COULD NOT BE DUPLICATED DURING TESTING. "REPLACE BATTERY" ALARMS WERE OBSERVED IN THE PUMP'S ALARM HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO PROBLEMS OBSERVED. 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. 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

    THE PATIENT REPORTED THAT SHE RECEIVED A LOW BATTERY WARNING BUT DID NOT RECEIVE A REPLACE BATTERY WARNING ON THE PUMP AND THE PUMP SHUT OFF. THE PATIENT REPORTED THAT THE PUMP WAS OFF FOR A FEW HOURS BEFORE SHE REALIZED IT, SHE DISCONNECTED AND CHANGED THE BATTERY. THE PATIENT REPORTED THAT SHE EXPERIENCED A BLOOD GLUCOSE (BG) OF 300-400MG/DL WITH POSSIBLE NAUSEA. THIS DOES NOT MEET ANIMAS' CRITERIA FOR A SERIOUS ADVERSE EVENT. THIS REPORT IS BEING MADE DUE TO POWER LOSS.

    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 24 YR