BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3123813 · Received May 22, 2013

    Report

    Report Number
    2531779-2013-06859
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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

    FOLLOW-UP #1 DATE OF SUBMISSION 07/25/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED A REBOOT OCCURRED ON (B)(6) 2013; NO BATTERY WARNINGS OR ALARMS WERE OBSERVED IN THE HISTORY PRIOR TO THE EVENT. THE BATTERY VOLTAGE WAS ABOVE THE THRESHOLD FOR ALARMS AND WARNINGS ACCORDING TO THE PUMP HISTORIES. THE BATTERY RETURNED WITH THE PUMP WAS AN ENERGIZER ULTIMATE LITHIUM, AND WAS FOUND TO BE DISCHARGED. A NEW BATTERY WAS USED TO COMPLETE INVESTIGATION. THE BATTERY COMPARTMENT AND CAP ARE INTACT AND ABLE TO MAINTAIN ELECTRICAL CONNECTION. THE PUMP POWERED ON APPROPRIATELY TO THE VERIFY SCREEN. THE BATTERY CAP WAS TIGHTENED AND THEN UNSCREWED A HALF TURN, AND NO REBOOTING OCCURRED. A REPLACE BATTERY ALARM AND A LOW BATTERY WARNING WERE DUPLICATED DURING TESTING, AND THE PUMP EMITTED THE APPROPRIATE AUDIO-VISUAL ALERTS. BOTH THE ALARM AND THE WARNING WERE CORRECTLY RECORDED IN THE PUMP¿S ALARM HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. THE PUMP COVER WAS REMOVED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT. THE PUMP WAS TESTED WITH AN EXTERNAL POWER SUPPLY AND ALL CURRENT DRAWS WERE FOUND TO BE WITHIN SPECIFICATION. THE COMPLAINT OF THE PUMP AND BATTERY BEING HOT AND THE POWER LOSS COULD NOT BE DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING SHE AWOKE THAT MORNING AND THE INSULIN PUMP WAS HOT. THE PATIENT REPORTED THAT SHE REMOVED THE BATTERY FROM THE PUMP, AND IT WAS ALSO HOT. THE PATIENT DENIED ANY MOISTURE OR BATTERY LEAKAGE. THE PATIENT CONFIRMED USING A 1.5 VOLT LITHIUM BATTERY IN THE PUMP. THE PATIENT FURTHER REPORTED THAT THE PUMP HAD NO POWER. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225919 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR