BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3871686 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16877
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/17/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT MULTIPLE REPLACE BATTERY ALARMS WERE RECORDED. VISUAL INSPECTION REVEALED THAT THERE WAS MOISTURE BEHIND THE DISPLAY LENS. THE BATTERY COMPARTMENT WAS INTACT; NO DAMAGE WAS OBSERVED. THE PUMP CASE WAS FOUND TO BE CRACKED IN THE RIGHT-HAND CORNER OF THE DISPLAY AREA. THE RETURNED BATTERY CAP WAS ABLE TO BE FULLY SECURED TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. DURING TESTING, THE PUMP EMITTED A REPLACE BATTERY ALARM ON EACH ATTEMPT TO PERFORM THE REWIND STEP. PARTIAL CURRENT DRAWS WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. ¿LOAD AND REWIND¿ CURRENT DRAWS WERE UNABLE TO BE MEASURED DUE TO INTERNAL MOISTURE CONTAMINATION. A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND AT A CRACK IN THE PUMP CASE. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE THE PUMP.

    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 POWER (BATTERY LIFE) ISSUE. IT WAS REPORTED THAT THE PUMP'S BATTERY LIFE DID NOT MEET THE EXPECTATIONS OF THE USER. 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
    350925 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR