BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4900799 · Received July 8, 2015

    Report

    Report Number
    2531779-2015-22818
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    June 21, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 8/18/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: A "BATTERY LIFE" ISSUE WAS NOT DUPLICATED DURING INVESTIGATION. BLACK BOX SHOWS EVIDENCE OF BATTERY ALARMS AND SHORT BATTERY LIFE. CURRENT DRAWS WITHIN SPECIFICATIONS. BATTERY CAP IS ABLE TO FULLY TIGHTEN HOWEVER BATTERY CAP THREADS DAMAGED. BATTERY COMPARTMENT CRACK OBSERVED BELOW GRIP PAD. EVIDENCE OF MOISTURE CONTAMINATION INSIDE BATTERY COMPARTMENT AND UNDERSIDE OF BATTERY CAP. UNRELATED TO THE COMPLAINT, THE PUMP POWERS WITH RETURNED BATTERY CAP TO A DIM DISCOLORED DISPLAY. LEAK TEST PASSES. REMOVED PUMP CASE AND DISASSEMBLED PUMP. EVIDENCE OF ADDITIONAL MOISTURE CONTAMINATION INSIDE PUMP. 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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. 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
    442934 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR