BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2882617 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14957
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - 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 HISTORY SHOWED AN EMPTY CARTRIDGE ALARM ON (B)(4) 2012 AT 3:59 AND THE ALARM WAS CONFIRMED AT 6:49, FOLLOWED BY A REPLACE BATTERY ALARM AT 6:49. THE VOLTAGE OF THE BATTERY PRIOR TO THE EMPTY CARTRIDGE ALARM WAS LOW. THE PUMP WAS IN USE UNTIL (B)(4) 2012 WITH NO FURTHER POWER ISSUES OCCURRING. THERE WAS NO VISIBLE DAMAGE TO THE BATTERY CAP OR COMPARTMENT. THE BATTERY CAP CONTACT HEIGHT AND WIDTH WERE FOUND TO BE IN SPECIFICATION AND THE CAP SECURED TO THE PUMP APPROPRIATELY. THE PUMP POWERED ON APPROPRIATELY AND WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR POWER ISSUES OCCURRING. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND NO DEFECTS WERE FOUND. A REPLACE BATTERY ALARM WAS REPRODUCED DURING TESTING AND THE PUMP ALARMED APPROPRIATELY. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT THE PUMP HAD INTERMITTENT POWER. THE PATIENT NOTED NO DAMAGE OR CORROSION TO THE PUMP, AND THE PUMP HAD NOT BEEN EXPOSED TO MOISTURE. THE PATIENT REPLACED THE BATTERY CAP AND BATTERY TO NO AVAIL. THE BATTERY CAP WAS TIGHT AND SECURE. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR