BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2875070 · Received December 17, 2012

    Report

    Report Number
    2531779-2012-14621
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    November 24, 2012
    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

    FOLLOW-UP #1: DATE OF SUBMISSION 11/11/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX REVEALED UNEXPLAINED PUMP REBOOTS HOWEVER THE ORIGINAL COMPLAINT WAS UNABLE TO BE DUPLICATED DURING THE INVESTIGATION. THE PUMP WAS RUN ON A 24 HOUR BASAL PROGRAM USING THE RETURNED BATTERY CAP AND THERE WAS NO INTERMITTENT POWER OR REBOOT OCCURRENCES. THE PUMP WAS OPENED AND THE POWER CIRCUIT WAS INSPECTED AND THERE WERE NO DEFECTS FOUND. THERE WAS NO MOISTURE FOUND INTERNALLY. THE RETURNED BATTERY CAP WAS USED TO PERFORM THIS INVESTIGATION. THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT THREADS OR THE BATTERY CAP. THE BATTERY CAP THREADS TIGHTENED PROPERLY AND THE BATTERY CAP CONTACTS WERE WITHIN SPECIFICATIONS. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED BELOW THE BUMPER AT THE CASE SEAL. THE DISPLAY APPEARED TO BE DIM AND DISCOLORED WHEN THE PUMP WAS POWERED ON. ADDITIONALLY, THE CARTRIDGE CAP WAS DAMAGED AT THE TOP BUT WAS ABLE TO SECURELY ATTACH TO THE PUMP. 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. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR