BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3454328 · Received November 7, 2013

    Report

    Report Number
    2531779-2013-19916
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Report Date
    October 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRAND NAME IS ONETOUCH PING GLUCOSE MGMT SYSTEM AND NOT ANIMAS INSULIN CARTRIDGE AS PREVIOUSLY REPORTED. THE MODEL NUMBER IS ONETOUCH PING INSULIN PUMP AND NOT ANM IR1200/1250/2020/OTP CART. THE TYPE OF DEVICE IS INSULIN INFUSION PUMP AND NOT INSULIN PUMP CARTRIDGE. THE PMA/510(K) # IS K080639 AND NOT K032257.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 3 DATE OF SUBMISSION 01/27/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/14/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED MULTIPLE LOSS OF PRIMES WITH NON-ZERO FORCE WERE RECORDED. DURING INVESTIGATION, NO LOSS OF PRIMES OCCURRED. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND THE FORCE SENSOR WAS FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. THE ¿LOSS OF PRIME¿ ISSUE WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 12/04/2013 - DEVICE EVALUATION:THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 11/22/2013 WITH THE FOLLOWING FINDINGS:A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FORCE TEST AND FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THEIR PUMP WAS LOSING PRIME ONCE OR TWICE A WEEK. 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
    574968 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR