BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2200827 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05778
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A "NO CARTRIDGE DETECTED" WARNING OCCURRED ONCE AFTER PERFORMING THE REWIND AND LOAD STEPS. THE FORCE SENSOR CALIBRATION AND RESISTANCE READING WAS FOUND TO BE WITHIN SPECIFICATIONS. THERE WAS NO DAMAGE FOUND TO THE FORCE SENSOR ASSEMBLY. THERE WAS NO CAUSE FOUND FOR THE "NO CARTRIDGE DETECTED" WARNING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. (B)(6). CORRECTION NUMBER - 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE STEP. THE PATIENT'S MOTHER INDICATED THAT THE PUMP DISPENSED ALL OF THE INSULIN 2 TIMES. THE PATIENTS MOTHER ATTEMPTED TO USE SALINE AND THE SALINE WAS DISPENSED DURING THE LOAD STEP.

    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 4 YR