BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3874476 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17105
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/12/2014 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) /2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT MULTIPLE ¿174: BASAL_EDIT_NOT_SAVED¿ WARNINGS WERE RECORDED ON 06/11/2014. THE BOLUS HISTORY SHOWED A TOTAL OF 10.65U DELIVERED ON (B)(4) 2014. THE BASAL AND BOLUS DELIVERIES ADDED UP CORRECTLY TO THE TOTAL DAILY DOSAGE RECORDED. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE AND THE PUMP REFLECTED 24 UNITS CORRECTLY IN THE BASAL HISTORY. ¿ADVANCED BOLUSES¿ WERE CORRECTLY DELIVERED AND RECORDED IN THE PUMP HISTORY. THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY WITHIN THE REQUIRED SPECIFICATIONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DIM. THE COMPLAINT THAT THE BASAL AND BOLUS HISTORIES DID NOT MATCH THE TOTAL DAILY DOSAGE HISTORY WAS NOT ABLE TO BE CONFIRMED DURING INVESTIGATION. 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 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER ALLEGED THAT THE TOTAL DAILY DOSAGE HISTORY DID NOT MATCH THE BASAL AND BOLUS HISTORY TOTALS ON (B)(6) 2014. 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
    352499 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR