BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3975233 · Received August 4, 2014

    Report

    Report Number
    2531779-2014-22170
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/29/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA CONFIRMED RECORD OF TIME AND DATE RESET. ON INVESTIGATION, THE PUMP WAS EXERCISED FOR 24 HOURS. THE PUMP WAS THEN POWERED DOWN FOR A TOTAL OF SIX HOURS AND THEN POWERED ON AGAIN. THE TIME AND DATE RESET TO THE FACTORY DEFAULT SETTING WHEN POWERED ON. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED THE INTERNAL TIME/DATA BATTERY WAS CORRODED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 SUBMITTED: 10/13/2014. DEVICE EVALUATION: REVIEW OF THE BLACK BOX DATA AND ALARM HISTORY REVEALED RECORD OF CALL SERVICE ALARM (078-0009) RECORDED. ON INVESTIGATION, THE PUMP POWERED ON AND EMITTED A CALL SERVICE ALARM (064-0008) DURING THE REWIND STEP. A LEAK TEST WAS PERFORMED AND REVEALED A MOISTURE LEAK; TESTING OF THE PUMP¿S ADVANCED FEATURES WERE NOT ABLE TO BE EVALUATED DUE TO THE MOISTURE LEAK. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED MOISTURE CORROSION PRESENT ON THE MOTOR WIRING AND CONNECTOR.

    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. 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 HISTORY/SETTINGS (TIME AND DATE RESET) ISSUE AND CALL SERVICE ALARM 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
    453792 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR