BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3031102 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03441
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/14/2013 WITH THE FOLLOWING RESULTS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION AT THE CONCLUSION OF THE 29HR FLOW ACCURACY TEST. THE CURRENT BLACK BOX AND ALARM HISTORY SHOW ONLY TYPICAL USAGE ALARMS AND WARNING; NOTHING RELATED TO COMPLAINT WAS OBSERVED. THE TDD HISTORY IS ACCURATE WHEN ADDING DELIVERED BASALS AND DELIVERED BOLUSES. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 INDICATING THAT THE PATIENT HAS BEEN OFF OF THE PUMP FOR 3 MONTHS BECAUSE THEY BELIEVE IT IS NOT DELIVERING CORRECTLY. THE REPORTER INDICATED THAT THEY COULD NOT REMEMBER WHAT THE PROBLEM WAS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING CORRECTLY. 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
    134997 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR