BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4093649 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26446
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    FOLLOW UP #1 SUBMITTED: 05/12/2016. 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. THE PUMP WAS RETURNED TO ANIMAS AND INVESTIGATED BY PRODUCT ANALYSIS ON 04/21/2016 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED RECORDS DATED (B)(6) 2016. THE DATA FROM THE DATE OF THE COMPLAINT HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP BY THE PATIENT. THE AVAILABLE RECORDS IN THE BLACK BOX REVEALED UNEXPLAINED EVENTS OF POWER ON RESET DATED (B)(6) 2016. ON INVESTIGATION, THE PUMP POWERED ON NORMALLY USING THE RETURNED BATTERY CAP. THE BATTERY CAP WAS EVALUATED AND FOUND TO MEET THE REQUIRED SPECIFICATIONS. THE BATTERY FIT SECURELY ON THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT LOSS OF POWER, REBOOTING OR CALL SERVICE ALARM OCCURRING. THE ALLEGED INTERMITTENT POWER ISSUE WAS NOT DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THE PUMP POWERED OFF AT NIGHT. THE PUMP WAS NOT AVAILABLE FOR TROUBLESHOOTING BY ANIMAS CUSTOMER SUPPORT AT THE TIME OF THE CALL. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER FOR FOLLOW UP, BUT WAS NOT SUCCESSFUL. THERE WAS NO HEALTH CONSEQUENCE TO THE PATIENT ASSOCIATED WITH THE REPORTED INCIDENT, AND NO MEDICAL TREATMENT OR HEALTH CARE PROVIDER INTERVENTION WAS REQUIRED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED POWER ISSUE REMAINED UNRESOLVED AT THE CONCLUSION OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573332 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR