BEUDAMED
    FDA Adverse Event Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3062981 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04404
    Date Received
    April 17, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP ALARM HISTORY INDICATED MULTIPLE POWER ON RESETS AND ¿REPLACE BATTERY¿ ALARMS. A LOW BATTERY VOLTAGE WAS NOTED IN PUMP HISTORY. THE BLACK BOX HISTORY INDICATED A PARTIALLY CHARGED BATTERY INSTALLED INTO THE PUMP. A VISUAL INSPECTION REVEALED NO DAMAGE FOUND TO THE BATTERY COMPARTMENT. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP. A NEW TEST BATTERY CAP WAS USED FOR TESTING PURPOSES. THE BATTERY CAP WAS FOUND TO TIGHTLY SECURE TO THE PUMP WITH NO VISIBLE YELLOW O-RING. THE PUMP SUCCESSFULLY POWERED ON WITH THE APPROPRIATE VIBRATORY AND AUDIBLE SOUNDS. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1.0 UNIT/HOUR BASAL PROGRAM USING THE NEW TEST BATTERY CAP; NO POWER ISSUES WERE NOTED. THE PUMP COVER WAS REMOVED; THERE WAS NO EVIDENCE OF INTERNAL MOISTURE AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT. 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 DISTRIBUTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THERE WAS REPORTEDLY NO SOUND UPON BATTERY INSERTION. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE FOR THIS COMPLAINT. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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
    166056 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1