BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3934938 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20079
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND TWO CANCELED BOLUS ON (B)(4) 2014, WITH WARNING OF THE USER SET LIMITS OF TOTAL DAILY DOSE BEING EXCEEDED. NO ACTIVITY OUTSIDE NORMAL USE WAS OBSERVED. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH AUDITORY AND VIBRATORY FEATURES. ALL THE BUTTONS RESPONDED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITH NO INCIDENCES. BOLUS EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. THE REPORTED BOLUS ISSUE WAS NOT VERIFIED IN THE BLACK BOX OR DUPLICATED IN THE INVESTIGATION. UNRELATED TO THE REPORTED BOLUS ISSUE, THE DISPLAY WAS FOUND TO BE DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. REPORTEDLY, THE PUMP ALERTED THAT THE LAST BOLUS HAD BEEN WITHIN 15 MINUTES WHEN THE PATIENT ATTEMPTED TO BOLUS. THE REPORTER STATED THAT THE LAST BOLUS WAS DELIVERED A COUPLE OF HOURS AGO. REVIEW OF BOLUS HISTORY CONFIRMED THAT NO BOLUS WAS DELIVERED WITHIN 15 MINUTES OF HAVING RECEIVED THE ALERT. THE PATIENT¿S GUARDIAN INDICATED THAT THEY HAVE LOST CONFIDENCE IN THE PUMP. 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
    412885 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR