BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4152939 · Received October 8, 2014

    Report

    Report Number
    2531779-2014-28659
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: (B)(4) 2014. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: SEVERAL LOSS OF PRIME WARNINGS, WHICH WERE DUE TO NON-ZERO-VALUE LOW FORCE READINGS AND CAN BE INDICATIVE OF THE TYPE OF ISSUE THAT WAS REPORTED, WERE OBSERVED IN THE BLACK BOX DATA. THE PUMP WAS EXERCISED FOR 24 HOURS, DURING WHICH NO LOSS OF PRIME WARNINGS WERE OBSERVED: THE REPORTED ISSUE WAS NOT DUPLICATED. THE PUMP PASSED A FORCE SENSOR CALIBRATION CHECK. THE PUMP SUCCESSFULLY PERFORMED THE BOLUS AND PRIME SEQUENCE FUNCTIONS. UNRELATED TO THE REPORTED ISSUE, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED FROM THE BOTTOM OF THE GRIP PAD TO THE CASE SEAL.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT A LOSS OF PRIME WARNING OCCURRED 3 OR MORE TIMES WITHIN A 30 DAY PERIOD, DURING WHICH AT LEAST 3 SEPARATE CARTRIDGES FROM 2 SEPARATE BOXES WERE USED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED 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
    632072 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR