BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3930437 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19798
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    July 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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, CORRECTION: SENT 08/04/2014: CUSTOMER SUPPORT'S REVIEW OF THE COMPLAINT CLARIFIES THAT THE LOW BLOOD GLUCOSE (BG) WAS NOT RELATED TO THE CRACKED PUMP CASING. THE REPORTER CONSIDERED THE LOW BG RELATED TO THE PATIENT NOT EATING AS MUCH BREAKFAST AS THE REPORTER HAD ANTICIPATED; THE PATIENT THEN ATE A BANANA AND WAS FINE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/18/2014 WITH THE FOLLOWING RESULTS: BATTERY COMPARTMENT IS CRACKED ON THREADS, DISPLAY IS DIM/FADING/REDDISH, CARTRIDGE AND BATTERY CAPS WERE NOT RETURNED WITH PRODUCT, A TEST BATTERY CAP WAS USED TO VERIFY STEPS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 47 MG/DL, WITH SHAKINESS AND COGNITIVE IMPAIRMENT. REPORTER ALSO ALLEGES THE PUMP HAS A CRACK IN THE BATTERY COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPOGLYCEMIA AND THE CRACKED CASING WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406766 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening