BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4093298 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26401
    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
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/30/2014 WITH THE FOLLOWING FINDINGS: THERE WERE PUMP REBOOTS OBSERVED IN THE BLACK BOX HISTORY IN REFERENCE WITH CLEARING ALARMS. THERE WERE CALL SERVICE (CS 052 AND CS054) ALARMS OBSERVED IN THE BLACK BOX HISTORY. UNRELATED TO THE ORIGINAL COMPLAINT, THE PUMP CASE WAS CRACKED AND WAS CONFIRMED WITH THE LEAK TEST. THE PUMP CASE WAS REMOVED AND THERE WAS EVIDENCE OF MOISTURE CONTAMINATION THROUGHOUT THE PUMP. ALSO UNRELATED, THERE WAS MOISTURE EVIDENCE BEHIND THE DISPLAY LENS. DUE TO INTERNAL MOISTURE CONTAMINATION, THE PUMP POWERED ON WITH AUDIO AND VIBRATION, BUT HAD AN UNREADABLE MULTI-COLORED DISTORTED DISPLAY IMAGE. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN AND THE BATTERY COMPARTMENT WAS INTACT. 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 POWER (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
    571180 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR