BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4221620 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31295
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 IT WAS EVALUATED BY PRODUCT ANALYSIS ON 12/18/2014 WITH THE FOLLOWING FINDINGS: A EAW 128-FXXX ALARM, WHICH IS DEFINED AS A POST DELIVERY MOTOR POWER SUPPLY FAULT AND CAN BE INDICATIVE OF THE TYPE OF ISSUE THAT WAS REPORTED, WAS NOT OBSERVED IN THE BLACK BOX OR HISTORY DATA. HOWEVER, EVIDENCE OF SHORT BATTERY LIFE WAS OBSERVED IN THE BLACK BOX DATA. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST BATTERY CAP, WHICH WAS ABLE TO SECURE TO THE PUMP PER THE INSTRUCTIONS FOR USE (IFU), WAS USED DURING THE ANALYSIS. THE BATTERY COMPARTMENT WAS OBSERVED TO BE INTACT. NO EAW 128-FXXX ALARMS WERE OBSERVED DURING THE ANALYSIS: THE REPORTED ISSUE WAS NOT DUPLICATED. EVALUATION REVEALED THAT THE PUMP DREW ELECTRIC CURRENT AT LEVELS WITHIN THE SPECIFICATIONS. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF INTERNAL DAMAGE OR DEFECT WAS FOUND. DURING THE ANALYSIS, THE PUMP OPERATED ACCORDING TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (128-FXXX) ISSUE. IT WAS REPORTED THAT A REPLACE BATTERY CODE BEGINNING WITH 128-FXXX (WHERE X IS ANY NUMBER OR LETTER) WAS PRESENT IN THE ALARM HISTORY AND HAD OCCURRED 3 OR MORE TIMES WITHIN A 30 DAY PERIOD. 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
    702297 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR