BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3213215 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-09961
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/12/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/22/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S HISTORY SHOWED MULTIPLE REBOOTS. DURING A VISUAL INSPECTION OF THE PUMP, NO DAMAGE WAS OBSERVED TO THE BATTERY COMPARTMENT. THE THREADS ON THE BATTERY CAP WERE STRIPPED AND THE CAP COULD NOT TIGHTEN ON TO THE PUMP; THE CAP¿S HEIGHT AND WIDTH CONTACTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE RETURNED BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION AND THE INTERMITTENT POWER ISSUE WAS DUPLICATED. A TEST CAP WAS USED AND WAS ABLE TO TIGHTEN ON TO THE PUMP. THE PUMP WAS THEN EXERCISED FOR 24 HOURS WITH NO LOSS OF POWER. THE PUMP COVER WAS REMOVED AND NO INTERNAL MOISTURE OR DAMAGE WAS FOUND TO THE POWER CIRCUIT OR BATTERY FLEX.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP WAS INTERMITTENTLY REBOOTING FOR ABOUT A MONTH. THE PATIENT REPORTED HAVING SOME ELEVATED BLOOD GLUCOSE LEVELS UP TO 270 MG/DL WITH ¿A STRANGE SMELL IN HIS NOSE.¿ THE PATIENT CONFIRMED NO KNOWN DAMAGE TO THE PUMP. THE REPORTED BLOOD GLUCOSE DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312733 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR