BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3071584 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04818
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/01/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY SHOWS NO EVIDENCE OF A ¿LOAD STEP MALFUNCTION.¿ ONE ¿NO CARTRIDGE DETECTED¿ WARNING WAS OBSERVED ON THE REPORTED DATE AS A RESULT OF A LOAD ATTEMPT AFTER AN ¿EMPTY CARTRIDGE¿ WARNING WITHOUT REWINDING. DURING TESTING THE PUMP POWERED ON AND WAS PRIMED SUCCESSFULLY; NO ¿LOAD STEP MALFUNCTION¿ WAS DUPLICATED. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO DEFECT WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE PUMP REPORTEDLY DID NOT RECOGNIZE A FILLED CARTRIDGE AND DISPENSED INSULIN DURING THE LOAD CARTRIDGE STEP. 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
    172954 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR