BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3161658 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08055
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/29/2013 WITH THE FOLLOWING RESULTS: PUMP HISTORY SHOWS PUMP WAS IN USE FOR LESS THAN 24 HOURS. "PUMP NOT PRIMED" WARNINGS OBSERVED IN THE BLACK BOX FORCE READINGS DO NOT REACH ZERO. REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR IS DETECTING CORRECT FORCE AT 5LBS. PUMP PASSED 29 HOUR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO LOSS OF PRIMES OCCURRED DURING TESTING. A LOSS OF PRIME WAS INDUCED AND THE PUMP GAVE THE APPROPRIATE VISUAL AND AUDIBLE ALERT. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT. 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. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE PUMP USER GUIDE INSTRUCTS THE PATIENT TO PRIME THE PUMP UNTIL 5 DROPS ARE SEEN COMING FROM THE END OF THE TUBING. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PUMP WOULD NOT PRIME AND BLOOD GLUCOSE LEVELS ELEVATED TO OVER 1000 MG/DL. THE PATIENT INDICATED THAT THE PUMP WAS DISCONTINUED AND INJECTIONS WERE GIVEN TO TREAT THE BLOOD GLUCOSE LEVELS. THE PATIENT REPORTED HAVING NO BATTERY FOR THE PUMP AT THE TIME OF THE CALL INTO ANIMAS AND THE PATIENT WAS UNABLE TO TROUBLESHOOT THE PUMP DURING THE CALL. ANIMAS ATTEMPTED TO FOLLOW UP WITH THE PATIENT TO TROUBLESHOOT THE EVENT BUT HAS BEEN UNSUCCESSFUL AT THIS TIME. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262973 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening