BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4344010 · Received December 18, 2014

    Report

    Report Number
    2531779-2014-36434
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Report Date
    November 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 3/12/15. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/23/2015 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. THE BLACK BOX SHOWS UNEXPLAINED POR ON 11/30/2014 15:58. WHEN PUMP WAS POWERED BACK ON THE TIME/DATE WAS SET TO 12/30/2014 16:09. A MANUAL DATE/TIME CHANGE WAS MADE FROM 12/30/2014 22:16 TO 11/30/2014 22:16. PUMP WAS EXERCISED FOR 24HRS WITH A 2.0U/HR BASAL RATE; AT END TESTING THE BASAL HISTORY CORRECTLY SHOWED. 2.0U AND TDD HISTORY SHOWED 48.0U. NO ALARMS RELATED TO THE COMPLIANT IN ALARM HISTORY. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. RETURNED CARTRIDGE CAP/RETURNED BATTERY CAP USED TO COMPLETE TESTING. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD BLOOD GLUCOSE (BG) LEVELS BETWEEN 200 AND 500 MG/DL WITH POLYURIA. DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND THAT THE TIME WAS CORRECT, BUT DATE WAS INCORRECT, AND THAT THE BASAL HISTORY DOES NOT MATCH ACTIVE BASAL PROGRAM. THE BG EXCURSION DOES NOT MEET ANIMAS CRITERIA FOR A REPORTABLE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DISCREPANCY IN THE BASAL HISTORY WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834141 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR