BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4092574 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26354
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 10/31/2014 WITH THE FOLLOWING FINDINGS: THE REPORTED NO-POWER ISSUE COULD NOT BE ADEQUATELY INVESTIGATED DUE TO A BLANK-DISPLAY ISSUE, AND THUS NO CONCLUSIONS COULD BE DETERMINED IN THIS REGARD. THERE WERE NO POWER-REBOOT EVENTS, WHICH WOULD BE PRESENT IN THE CASE OF A NO-POWER ISSUE, OBSERVED IN THE BLACK BOX DATA. HOWEVER, A CS-054 CALL SERVICE ALARM, WHICH IS OFTEN MISTAKEN FOR A POWER FAILURE, WAS OBSERVED IN THE BLACK BOX DATA FROM THE ALERT DATE. MOISTURE WAS PRESENT BEHIND THE DISPLAY LENS. THE PUMP CASE WAS CRACKED NEAR THE RIGHT SIDE OF THE DISPLAY LENS. THE PUMP FAILED A LEAK TEST DUE TO THE PUMP CASE DAMAGE; THIS DEVICE FAILURE CAUSED THE MOISTURE INGRESS EVENT. THE PUMP POWERED ON, AS CONFIRMED BY THE PRESENCE OF THE AUDITORY AND VIBRATORY CUES; HOWEVER, THE DISPLAY SCREEN WAS BLANK DUE TO INTERNAL MOISTURE DAMAGE. THE PUMP CASE WAS REMOVED, AND MOISTURE DAMAGE WAS FOUND ON INTERNAL COMPONENTS. THE RELATION OF THE AFOREMENTIONED DEVICE FAILURES TO THE REPORTED NO-POWER ISSUE CAN NOT BE DETERMINED, AS THE REPORTED NO-POWER ISSUE WOULD HAVE TO BE DUPLICATED TO DETERMINE SUCH. UNRELATED TO THE REPORTED NO-POWER ISSUE, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED BELOW THE GRIP PAD.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT MOISTURE INGRESS WAS EVIDENT BEHIND THE DISPLAY LENS AND THE PUMP WAS EXPERIENCING A NO-POWER ISSUE. 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
    573654 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR