BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3250838 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-11971
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/17/2013 WITH THE FOLLOWING FINDINGS: NO ERRORS, ALARMS, OR WARNINGS WERE FOUND IN THE BLACK BOX RELATED TO THE COMPLAINT. THE BATTERY COMPARTMENT WAS CRACKED. THERE WAS NO EVIDENCE OF MOISTURE FOUND INSIDE THE BATTERY COMPARTMENT AND THE BATTERY CAP WAS ABLE TO BE FULLY TIGHTENED. A POWER LOSS WAS NOT OBSERVED. THE LEAK TEST REVEALED A LEAK AT THE DISPLAY LENS. THE PUMP CASE WAS REMOVED AND THERE WAS EVIDENCE OF MOISTURE CONTAMINATION IDENTIFIED INSIDE THE PUMP ON THE TRANSCEIVER BOARD, KEYPAD FLEX CABLE AND CONNECTOR. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS DIM, DISCOLORED, AND DIFFICULT TO READ. THE PUMP COVER WAS REMOVED AND THE DISPLAY SCREEN WAS REPLACED WITH A NEW SCREEN FOR TESTING. ONCE COMPLETED, THE CONTRAST RETURNED TO NORMAL WITH NO DISCOLORATION OF TEXT. 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 A POWER (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT THE PUMP WOULD NOT POWER ON AFTER EXPOSING PUMP TO MOISTURE. BATTERY WAS CHANGED, BUT IT DID NOT RESOLVE THE 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
    353824 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR