BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3864183 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16410
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 DATE OF SUBMISSION 07/10/2014-DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/02/2014 WITH THE FOLLOWING FINDINGS:A VISUAL INSPECTION OF THE PUMP SHOWED THAT THE BUMPER PAD HAD COME LOOSE OFF FROM THE PUMP. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS DIM AND DISCOLORED. THE BATTERY CAP WAS CRACKED AND HALF OF THE CAP THREADS WERE CRACKED OFF FROM 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 DATE OF SUBMISSION 06/24/2014:ADDITIONAL INFORMATION:THE REPORTER CONTACTED ANIMAS ON 06/09/2014 TO REPORT THE ADDITIONAL INFORMATION THAT THE BUMPER GRIP PAD WAS THE PART OF THE PUMP THAT HAD FALLEN OFF. THIS IS GENERALLY NOT CONSIDERED A REPORTABLE ISSUE AS IT IS AN INCONVENIENCE AND DOES NOT AFFECT INSULIN DELIVERY FUNCTION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 STATING THAT THE ¿BOTTOM FELL OUT OF THE PUMP.¿ THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337834 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR