BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192385 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09073
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) 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 SHOWED NO CARTRIDGE DETECTED AND MULTIPLE LOSS OF PRIMES DUE TO ZERO FORCE WARNINGS. THE PUMP POWERS ON AND DISPLAYS VERIFY SCREEN. THE DISPLAY SCREEN IS DIM AND REDDISH. A TEST DISPLAY WAS MOUNTED DURING INVESTIGATION AND SCREEN FULLY ILLUMINATED. THE PUMP PASSES EZ PRIME STEPS AND PRIMES CORRECTLY. INVESTIGATORS WERE UNABLE TO DUPLICATE REPORTED LOAD STEP MALFUNCTION. FORCE SENSOR CALIBRATION READING IS AT THE HIGHEST COUNT. PUMP¿S COVER WAS REMOVED, MOISTURE CORROSION WAS OBSERVED INSIDE THE UNIT FOUR-THE FORCE SENSOR CIRCUIT WAS DISASSEMBLED, MOISTURE CORROSION WAS FOUND TO THE FORCE SENSOR PLATE. FORCE SENSOR RESISTANCE READING IS WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER STATED THAT THE PUMP EMPTIED THE CARTRIDGE OF INSULIN DURING THE LOAD 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
    292633 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR