BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3031515 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03452
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 06/18/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: BLACK BOX REVIEW SHOWS NO EVIDENCE OF LOAD STEP MALFUNCTION, NO ACTIVITY OUTSIDE OF NORMAL USE IS OBSERVED. THE PUMP POWERS ON AND DISPLAYS VERIFY SCREEN. THE DISPLAY SCREEN WAS OBSERVED TO BE DIM AND FADED. A TEST DISPLAY SCREEN WAS MOUNTED DURING INVESTIGATION, THE PUMP WAS ABLE TO BOOT UP WITH A FULLY FUNCTIONAL AND ILLUMINATED DISPLAY. THE PISTON IS UNABLE TO DETECT THE CARTRIDGE UPON THE FIRST LOAD ATTEMPTS. THE KEYPAD SYMBOLS WERE FOUND TO BE WORN. THE REPORTED LOAD STEP MALFUNCTION WAS DUPLICATED. FORCE SENSOR CALIBRATION READING IS BELOW THE REQUIREMENTS. THE PUMP WAS OPENED, FORCE SENSOR PINS WERE FOUND INTACT. AFTER DISASSEMBLING THE FORCE SENSOR CIRCUIT, CONTAMINATION WAS OBSERVED TO THE FORCE SENSOR PLATE. FORCE SENSOR RESISTANCE WAS FOUND ABOVE SPECIFICATIONS.

    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 WAS DISPENSING 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
    135234 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR