BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3801504 · Received May 9, 2014

    Report

    Report Number
    2531779-2014-13089
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    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

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A LOSS OF PRIME ASSOCIATED WITH ZERO FORCE AND A NO CARTRIDGE DETECTED ALARM. LOSSES OF PRIME WERE ALSO RECORDED DUE TO FAILURE TO PRIME THE TUBING WITHIN THREE MINUTES OF INITIATING THE PRIME STEPS. A PRIME ISSUE WAS NOT DUPLICATED DURING TESTING. THE FORCE SENSOR CALIBRATION READING WAS WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO DEFECTS WERE FOUND TO THE FORCE SENSOR CIRCUIT. THE FORCE SENSOR RESISTANCE READING WAS WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. NO MOISTURE OR CORROSION WAS FOUND INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (PRIME ISSUE) ISSUE. THE REPORTER STATED THAT THE PUMP INITIATED THE REWIND STEP WITHOUT USER INTERVENTION. 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
    280472 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR