BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2851958 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14099
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 03/19/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: BLACK BOX SHOWS NO EVIDENCE OF "LOAD STEP MALFUNCTION". THE PUMP BOOTED NORMALLY, "EZ-PRIME" OPERATION PERFORMED SUCCESSFULLY AND PUMP WAS ABLE TO PRIME NORMALLY. THE PUMP WAS OPENED, NO DAMAGE OR MOISTURE INGRESS WAS FOUND TO THE FORCE SENSOR CIRCUIT OR TO THE POWER CIRCUIT. FORCE SENSOR RESISTANCE READING WAS CHECKED AND WAS FOUND WITHIN SPECIFICATION. UNRELATED TO THE COMPLAINT, THE FORCE SENSOR CALIBRATION IS READING THE HIGHEST COUNT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (POTENTIAL LOAD STEP MALFUNCTION) ISSUE. THE PATIENT REPROTED SINCE SHE BEGAN USE OF PUMP A COUPLE OF WEEKS PRIOR, THE PUMP ONLY PRIMES 2 TO 3 UNITS BEFORE SEEING THE INSULIN COME OUT OF THE TUBING. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR