BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3231318 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11071
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 DATE OF SUBMISSION 10/10/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/17/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S HISTORY SHOWED NO ERRORS, ALARMS, OR WARNINGS RELATED TO THE COMPLAINT. THE BATTERY CAP WAS OBSERVED TO BE CRACKED DURING EVALUATION. EVIDENCE OF MOISTURE CORROSION WAS FOUND IN THE BATTERY COMPARTMENT AND THE PUMP FAILED A LEAK TEST DUE TO THE CRACK. DURING TESTING, THE PUMP POWERED ON NORMALLY. UNRELATED TO THE COMPLAINT, THE PUMP¿S HISTORY SHOWED EVIDENCE OF A TIME AND DATE RESET TO FACTORY DEFAULT. THE PUMP COVER WAS REMOVED AND THE INTERNAL BATTERY WAS FOUND TO BE LEAKING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT T HIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/17//2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THEIR PUMP WAS REBOOTING WITH A NEW BATTERY. UPON INSPECTION OF THE DEVICE THE REPORTER NOTED THAT THERE WAS SOME CORRUPTION WITHIN THE BATTERY CHAMBER ON THE BATTERY. THE REPORTER NOTED THAT AFTER THE BATTERY WAS CHANGED THE PUMP KEPT ASKING TO PRIME AND VERIFY AFTER REBOOTING. 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
    330772 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR