BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4152980 · Received October 8, 2014

    Report

    Report Number
    2531779-2014-28632
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/04/2015. 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/21/2015 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED INFORMATION FROM JUNE 30, 2014 THROUGH JULY 8, 2014. THERE WAS NO EVIDENCE OF A ¿NO POWER¿ EVENT IN AVAILABLE BLACK BOX DATA. ON EXAMINATION, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED AT THE COMPARTMENT THREADS AND BELOW THE GRIP PAD. ON INVESTIGATION, THE PUMP POWERED ON USING THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP. THE BATTERY CAP THREADS WERE FOUND TO BE DAMAGED; HOWEVER, THE CAP WAS ABLE TO BE FULLY TIGHTENED ONTO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT INTERRUPTION IN POWER OR THE OCCURRENCE OF ERRORS, ALARMS OR WARNINGS. INVESTIGATION DID NOT DUPLICATE THE ¿NO POWER¿ COMPLAINT. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF DAMAGE, DEFECT OR CONTAMINATION OF THE PUMP¿S INTERIOR COMPONENTS. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS NOTED TO BE DIM, FADED AND DISCOLORED.

    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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632159 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1