BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3060377 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04289
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 18, 2012
    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 WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DISPLAY IS FADED, DISCOLORED AND DIFFICULT TO READ. REPLACED FADED DISPLAY WITH TEST DISPLAY. THE TEST SCREEN IS FULLY FUNCTIONAL AND IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION. BATTERY COMPARTMENT CRACKED FROM BUMPER PAD TO CASE SEAL. NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT. BATTERY CAP RETURNED WITH PUMP IS ABLE TO BE FULLY TIGHTENED, NO POWER LOSS OBSERVED. NO EVIDENCE OF EXCESSIVE BATTERY USAGE OBSERVED IN BLACK BOX. REMOVED PUMP CASE. NO EVIDENCE OF MOISTURE CONTAMINATION WAS IDENTIFIED INSIDE PUMP. INSPECTED BATTERY TERMINAL CONTACTS, NO EVIDENCE OF INTERMITTENT CONTACT. 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. (B)(6).

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A DIM/DISCOLORED DISPLAY AND A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162191 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1