BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2781531 · Received October 10, 2012

    Report

    Report Number
    2531779-2012-12124
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 DATE OF SUBMISSION (B)(4) 2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. VISUAL INSPECTION REVEALED NO PHYSICAL OR MOISTURE DAMAGE TO THE BATTERY COMPARTMENT. A TEST BATTERY CAP WAS USED TO COMPLETE INVESTIGATION. THE BATTERY CAP SECURES APPROPRIATELY TO THE PUMP. THE PUMP POWERS ON APPROPRIATELY TO THE VERIFY SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THE DISPLAY IS FULLY INTACT AND LEGIBLE. A REVIEW OF THE BLACK BOX INDICATES SEVERAL REBOOTS AND OCCLUSION ALARMS DURING THE TIME OF THE REPORTED EVENT. THE BLACK BOX SHOWS THAT THE PUMP WOULD NOT RUN DUE TO THE HIGH FORCE NOT BEING CLEARED FOR THE OCCLUSION ALARM. THE BLACK BOX ALSO REVEALED THAT AN "EXPIRED" BATTERY WAS BEING USED FOR A BATTERY CHANGE DURING THE REPORTED EVENT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OR OCCLUSIONS OCCURRING. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THE ANIMAS INSULIN PUMP HAS POWER ISSUES. THE SUBJECT PUMP ALLEGEDLY WILL NOT POWER ON AFTER THE PATIENT WAS UNABLE TO RESOLVE A CALL SERVICE ALARM ISSUE. THE SUBJECT PUMP DID NOT HAVE PHYSICAL DAMAGE OR MOISTURE WITHIN. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE POWER ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR