BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4914200 · Received July 14, 2015

    Report

    Report Number
    2531779-2015-23666
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Report Date
    June 26, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/03/2105 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED AN UNCONFIRMED REPLACE CARTRIDGE ALARM ON (B)(6) 2015 AT 04:15 WITH DELIVERIES RESUMING AT 09:09. THE BASAL HISTORY APPEARED TO BE INACCURATE DUE TO THE UNCONFIRMED ALARM. THE PUMP WAS EXERCISED FOR 24 HOURS WITH A 1.0U/HR BASAL RATE. AT THE END OF TESTING, THE BASAL HISTORY CORRECTLY SHOWED 1.0U AND THE TOTAL DAILY DOSE SHOWED 24.0U. NO ALARMS OCCURRED DURING TESTING. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN RANGE. UNRELATED TO THE INITIAL ALLEGATION, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BATTERY COMPARTMENT WAS CRACKED.

    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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BASAL HISTORY IN THE PUMP DID NOT MATCH THE ACTIVE BASAL PROGRAM. 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
    454703 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR