BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3140553 · Received May 31, 2013

    Report

    Report Number
    2531779-2013-07451
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    May 24, 2013
    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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/20/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED ONE LOW BATTERY ALARM IN BLACK BOX. THE BATTERY COMPARTMENT WAS INTACT. NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT AND THE BATTERY CAP IS ABLE TO FULLY TIGHTEN. THE CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE DISPLAY WAS FOUND TO BE FADED, DISCOLORED AND DIFFICULT TO READ. INVESTIGATORS WERE UNABLE TO DUPLICATE OR VERIFY EXCESSIVE BATTERY USAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THE REPORTER STATED THAT THEY CHANGED BATTERY YESTERDAY AND PUMP JUST DIED WITHOUT LOW BATTERY ALARM. ALARM HISTORY INDICATED BATTERY CHANGES OCCURRING FREQUENTLY. THE REPORTER DENIED MOISTURE OR TRAUMA AND NO CRACKS IN BATTERY COMPARTMENT. THE BATTERY CAP WAS INTACT. 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
    240711 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR