BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181735 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08720
    Event Type
    Malfunction
    Date Received
    June 21, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 08/21/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. PERFORMED 2 BOLUSES FROM THE PUMP AND 1 FROM A METER, ALL WERE DELIVERED CORRECTLY AND ALL WERE RECORDED IN THE BOLUS HISTORY CORRECTLY. THE NO DELIVERY PUMP SUSPENDED ALARMED AN HOUR AFTER THE LAST BUTTON PRESS. PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO ALARMS. PUMP WAS EXERCISED FOR 24 HRS. ON A 1UNIT PER HOUR BASAL PROGRAM WITH NO ALARMS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED THAT BOLUSES HAD NOT RECORDED IN THE HISTORY. THE PATIENT STATED THAT TWO BOLUSES HAD BEEN DELIVERED THROUGH THE METER REMOTE. A REVIEW OF THE BOLUS HISTORY FOR (B)(6) 2013 SHOWED ONLY ONE BOLUS AT 5:22 AM. IT WAS CONFIRMED THAT THE METER AND PUMP WERE COMMUNICATING. 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
    282146 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR