BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2954687 · Received February 11, 2013

    Report

    Report Number
    2531779-2013-01652
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 09/16/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP¿S BASAL HISTORY SHOWED DATA UP TO 07/30/2013. THERE WAS NO DATA IN THE PUMP HISTORIES FROM THE TIME OF THE REPORTED ISSUE DUE TO CONTINUED USE. DURING TESTING, THE PUMP FAILED TO RECOGNIZE THE CARTRIDGE DURING THE LOAD STEP. ADDITIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE INABILITY TO PRIME THE PUMP. A DISPLAY LENS LEAK WAS FOUND DURING THE LEAK TEST. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE INABILITY TO PRIME THE PUMP. THE PUMP WAS OPENED AND INTERNAL MOISTURE DAMAGE FOUND. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD HAD FAILED. THE COMPLAINT WAS UNABLE TO BE ADEQUATELY INVESTIGATED DUE TO MOISTURE DAMAGE.

    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP BASAL HISTORY WAS NOT RECORDING. THE REPORTER STATED THAT ALL OF THE OTHER HISTORIES RECORDED CORRECTLY BUT NOT THE BASAL. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP HISTORY ISSUE WHICH WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59312 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR