BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2071247 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02948
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    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: THE PUMP WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY; THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES FOUND. A REVIEW OF THE PUMP HISTORY FROM (B)(6) 2010 TO THE END OF PUMP USE ON (B)(6) 2011 INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP HISTORY REVEALED A MANUAL TIME CHANGE FROM (B)(6) 2011 06:14 TO (B)(6) 2011 18:14. THERE WAS NO EVIDENCE OF A TIME AND DATE RESET TO FACTORY DEFAULT SETTINGS NOTED IN THE PUMP HISTORY. THERE WERE NO DEFECTS FOUND TO THE INTERNAL CLOCK BATTERY. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE DATE/TIME ON THE ANIMAS PUMP IS SWITCHING FROM AM TO PM AND VICE VERSA. THERE WAS NO REPORT OF PRODUCT MISUSE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT AS THE PATIENT DID NOT HAVE ANY SYMPTOMS OR MEDICAL INTERVENTION. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE DATE/TIME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR