BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2912447 · Received January 12, 2013

    Report

    Report Number
    2531779-2013-00580
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Report Date
    December 18, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE DATA FROM THE REPORTED EVENT DATE IS UNAVAILABLE FOR REVIEW AS IT HAS BEEN OVERWRITTEN DUE TO CONTINUED PUMP USE. UNUSUAL PRIME AMOUNTS WERE OBSERVED IN THE PUMP HISTORY, WHICH WAS NOT DUPLICATED DURING INVESTIGATION. THE PUMP POWERED ON NORMALLY AND EZPRIME STEPS WERE SUCCESSFULLY PERFORMED. NO ALARMS OCCURRED DURING TESTING. THERE WAS NO DAMAGE FOUND TO THE FORCE SENSOR CIRCUIT OR THE PCB, AND THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATION. THE COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION. 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.

    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 REQUIRED A VERY LOW PRIME VOLUME. ON AVERAGE A COMFORT 17 M TUBING REQUIRES 10-15 UNITS OF INSULIN TO PRIME. THE PATIENT'S PRIME SESSION ONLY TAKES FROM 1 UNIT TO 5 UNITS. 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
    19413 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR