BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3791485 · Received May 5, 2014

    Report

    Report Number
    2531779-2014-12534
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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 05/27/2014-PRODUCT ANALYSIS:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/20/2014 WITH THE FOLLOWING FINDINGS:THE COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION. A REVIEW OF THE PUMP¿S BLACK BOX REVEALED RELATED ALARMS. THE BATTERY COMPARTMENT WAS OBSERVED TO BE UNDAMAGED. THE BATTERY CAP WAS ABLE TO PROPERLY SECURE TO THE PUMP. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE AND DELIVERED BOLUSES WITHOUT ISSUE OR ALARM. THE PUMP¿S ELECTRIC CURRENT DRAWS WERE FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO EVIDENCE OF DAMAGE OF DEFECT TO THE PUMP¿S INTERNAL COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (128-FXXX) LOW-BATTERY 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
    266839 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR