BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3250463 · Received July 26, 2013

    Report

    Report Number
    2531779-2013-11959
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/09/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/18/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP¿S HISTORY SHOWED MULTIPLE PUMP REBOOTS WERE RECORDED. DURING EVALUATION, THE BATTERY COMPARTMENT AND BATTERY CAP WERE FOUND TO BE INTACT. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP. THE BATTERY CAP HEIGHT AND WIDTH MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP REWIND, LOAD, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO LOSS OF POWER. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO LOSS OF POWER OCCURRING. THE PUMP WAS OPENED AND NO DEFECTS WERE FOUND TO THE POWER AND FORCE SENSOR CIRCUITS. THE INTERMITTENT POWER ISSUE WAS NOT ABLE TO BE DUPLICATED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS REPORTED THAT THE PUMP REBOOTED SEVERAL TIMES WITHOUT USER INTERVENTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349848 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR