BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2912446 · Received January 12, 2013

    Report

    Report Number
    2531779-2013-00579
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Report Date
    December 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1: SUBMITTED: (B)(6) 2013. DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY DID NOT SHOW ANY LOSS OF PRIME WARNINGS OR NO CARTRIDGE DETECTED WARNINGS. LOW DELIVERY FORCE WAS OBSERVED IN THE IN THE BLACK BOX. ON TESTING, AN EZ-PRIME OPERATION WAS EXECUTED AND DURING THE LOAD STEP, THE PUMP FAILED TO RECOGNIZE THE CARTRIDGE AND EJECTED THE FLUID FROM THE CARTRIDGE. THE PUMP APPROPRIATELY EMITTED A NO CARTRIDGE DETECTED WARNING. THE FORCE SENSOR WAS TESTED AND FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED CONTAMINATION PRESENT ON THE FORCE SENSOR ASSEMBLY. RECALL # 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CLAIMED THE ANIMAS INSULIN PUMP HAS A LOAD STEP ISSUE. THE SUBJECT PUMP ALLEGEDLY PRIMED 51-64 UNITS OF INSULIN WITHIN THE CARTRIDGE WHEN THE PATIENT PERFORMED THE LOAD STEP. THE AMOUNT OF INSULIN EXPELLED IS NOT NORMAL BASED ON HER PREVIOUS LOAD STEP. AT THE TIME OF CONCERN, THE SUBJECT PUMP DID NOT PROMPT A NO CARTRIDGE DETECTED WARNING. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PRODUCT WAS REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE LOAD STEP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19357 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR