BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2472148 · Received February 29, 2012

    Report

    Report Number
    2531779-2012-01613
    Event Type
    Malfunction
    Date Received
    February 29, 2012
    Report Date
    January 30, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED DURING THE LOAD STEP. DURING EVALUATION THE PUMP WAS ABLE TO DETECT THE CARTRIDGE DURING THE LOAD STEP. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR ASSEMBLY.

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER 2531779-03/24/2010-003-R. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT REPORTED AN ISSUE WITH THE LOAD STEP OF THE CARTRIDGE PLACEMENT SEQUENCE. IT WAS REPORTED THAT DURING THE PAST 4 ½ YEARS THE LOAD STEP SEEMED TO BE PUSHING INSULIN THROUGH THE TUBING, PRIOR TO THE PRIME STEP. THE PATIENT STATED THAT HE FILLED THE CARTRIDGES TO THE 2.0ML MARK; THE PUMP READ THAT THE CARTRIDGE HAD ABOUT 172-182 UNITS OF INSULIN REMAINING IN THE CARTRIDGE AFTER THE REWIND AND LOAD STEP. HE SAID THAT HE NEVER REPORTED THIS ISSUE UNTIL NOW. THE PATIENT REPORTED THAT OVER THE LAST MONTH, THE LOAD STEP NOW EMPTIES SOME OF THE CARTRIDGE (THROUGH THE TUBING) AND WHEN THE LOAD STEP STOPS THE INSULIN REMAINING IN THE CARTRIDGE READS 120-150 UNITS. THE PATIENT ESTIMATED THAT 20-30 UNITS DISPENSED BEFORE THE PUMP RECOGNIZED THE CARTRIDGE. THERE WAS NO REPORT OF BLOOD GLUCOSE EXCURSIONS RELATED TO THIS ISSUE. THE COMPLAINT IS BEING REPORTED BECAUSE OF THIS ALLEGED INSULIN DELIVERY 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 56 YR