BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3942144 · Received July 17, 2014

    Report

    Report Number
    2531779-2014-20492
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 11/15/2014 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED BETWEEN THE BUMPER PAD AND THE TOP. EVIDENCE OF MOISTURE CORROSION WAS FOUND INSIDE THE BATTERY COMPARTMENT. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS FOUND. THE RETURNED BATTERY CAP WAS FOUND TO BE STRIPPED. THE BATTERY CAP CONTACT HEIGHT WAS FOUND TO BE OUT OF THE REQUIRED SPECIFICATIONS. THE BATTERY CAP CONTACT WIDTH WAS FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. A TEST BATTERY CAP WAS USED TO COMPLETE TESTING. THE PUMP WAS NOT ABLE TO BE POWERED ON DUE TO THE MOISTURE DAMAGE IN THE BATTERY COMPARTMENT. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE CORROSION WAS FOUND INSIDE THE 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THE BATTERY CAP WAS NOT ABLE TO BE REMOVED FROM THE PUMP. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION IN THE PUMP. THE BATTERY CAP WAS ABLE TO BE REMOVED DURING TROUBLESHOOTING. 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
    420428 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR