BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1926112 · Received November 24, 2010

    Report

    Report Number
    2531779-2010-02476
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 24, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER GUIDE INSTRUCTS USERS TO DISCONNECT FROM THE INFUSION SET PRIOR TO INITIATING THE PRIME / REWIND SEQUENCE. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET PRIOR TO INITIATING THE REWIND OF THE MOTOR. THE USER MUST MANUALLY CONFIRM THIS ALERT BEFORE PROCEEDING WITH THE REWIND PROCESS. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT THE PUMP WAS IN USE UNTIL (B)(6) 2011. THE DATE OF THE REPORTED EVENT WAS (B)(6) 2010. DUE TO CONTINUED PUMP USE, THE HISTORY FOR THE DATE OF THE REPORTED EVENT WAS UNAVAILABLE FOR REVIEW. DURING TESTING, REWIND, LOAD, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS OBSERVED. EVALUATION CONFIRMED THAT THE PUMP DISPLAYS THE APPROPRIATE WARNINGS FOR THE USER TO DISCONNECT FROM THE PUMP BEFORE PERFORMING THE REWIND, LOAD, AND PRIME STEPS. 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. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT SHE FILLED THE CARTRIDGE TO THE 1ML (100UNIT) MARK AND COMPLETED THE REWIND STEP WITH THE PT DISCONNECTED FROM THE PUMP. SHE THEN CONNECTED THE PT TO THE PUMP AND COMPLETED THE LOAD CARTRIDGE STEP. THE PUMP READ 68 UNITS FOLLOWING THE LOAD CARTRIDGE STEP. THE PT'S MOTHER BELIEVES THAT INSULIN WAS INADVERTENTLY INJECTED INTO THE PT DURING THE LOAD CARTRIDGE PHASE. NO ADVERSE EVENT OR BLOOD GLUCOSE EXCURSIONS WERE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR