BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4152952 · Received October 8, 2014

    Report

    Report Number
    2531779-2014-28653
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/19/2014 WITH THE FOLLOWING FINDINGS: THERE WAS ONE LOW BATTERY WARNING ON (B)(6) 2014 AT 13:26 AND A REPLACE BATTERY ALARM ON (B)(6) 2014 AT 13:43 OBSERVED IN THE BLACK BOX HISTORY. A STUCK VP WAS OBSERVED IN THE BLACK BOX ON (B)(6) 2014 WHICH RESULTED IN THE LESS THAN 30 MINUTE DURATION BETWEEN ALARMS. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP AND THE CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP. THE BATTERY COMPARTMENT WAS INTACT. CURRENT ELECTRICAL DRAWS WERE WITHIN SPECIFICATION. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOTS, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. THERE WERE NO POWER ISSUES DUPLICATED DURING THE INVESTIGATION. THE PUMP PASSED THE LEAK TEST AND NO EVIDENCE OF ADDITIONAL MOISTURE WAS OBSERVED INSIDE THE PUMP WHEN THE CASE WAS REMOVED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (POWER ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED A LOW BATTERY WARNING AND REPLACE BATTERY ALARM LESS THAN 30 MINUTES APART. 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
    632236 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR