BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3895656 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18265
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 23, 2014
    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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    FOLLOW-UP #1 DATE OF SUBMISSION 07/14/2014, ADDITIONAL INFORMATION:THE REPORTER CONTACTED ANIMAS ON 07/01/2014 AND REPORTED THAT AFTER REPLACING THE BATTERY FROM A NEWLY PURCHASED PACK, THE PUMP POWERED ON PROPERLY AND THERE WERE NO OTHER ISSUES NOTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2: DATE OF SUBMISSION 12/15/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX SHOWED THAT THE DATA FROM THE DATE OF THE COMPLAINT WAS OVERWRITTEN. THE COMPLAINT WAS UNABLE TO BE CONFIRMED OR DUPLICATED DURING THE INVESTIGATION. THE CURRENT BLACK BOX SHOWED NO EVIDENCE OF A ¿INTERMITTENT POWER¿ EVENT. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN AND THE CAP MEASURES WERE WITHIN SPECIFICATIONS. THE BATTERY COMPARTMENT WAS FOUND TO BE INTACT. THE PUMP WAS EXERCISED WITH THE RETURNED BATTERY CAP FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. THE PUMP CASE WAS REMOVED AND THERE WAS NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS INSIDE THE PUMP. UNRELATED TO THE ORIGINAL COMPLAINT, THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP TO A DIM AND DISCOLORED DISPLAY. ADDITIONALLY, THE BOLUS BUTTON COVER WAS TORN IN THE CENTER BUT THE BUTTON WAS RESPONSIVE. 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, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. REPORTEDLY, THE PUMP HAD INTERMITTENT POWER ISSUE. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP AND THE CAP WAS ABLE TO SECURE PROPERLY ON TO THE PUMP. THE REPORTER NOTED THAT THE ISSUE WAS NOT RESOLVED WITH A NEW BATTERY. 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
    371204 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR