BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3200981 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09465
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 5, 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

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: REVIEW OF THE BLACK BOX DATA REVEALED RECORDS FROM (B)(4) 2013. THIS COMPLAINT WAS LOGGED ON (B)(4) 2013. THERE IS NO BLACK BOX DATA TO SUPPORT THE TIMEFRAME OF (B)(4) 2013. ON EXAMINATION, THERE WAS NO DAMAGE TO THE PUMP CASING OR THE BATTERY CAP. THE BATTERY CAP WAS ABLE TO BE TIGHTENED TO THE PUMP PROPERLY. THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION FOUND IN THE BATTERY COMPARTMENT. ON INVESTIGATION, THE PUMP POWERED ON NORMALLY WITH A FULLY ILLUMINATED DISPLAY; HOWEVER, THERE WERE NO AUDIBLE TONES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF POWER DURING THE INVESTIGATION. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED AN AREA OF COLD SOLDER CONTAMINATION AFFECTING THE AUDIBLE TONE ASSEMBLY. A NEW TEST COVER WAS INSTALLED DURING THE INVESTIGATION AND THE AUDIBLE TONE WAS FUNCTIONAL. INVESTIGATION WAS UNABLE TO DUPLICATE THE LOSS OF POWER COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE OF UNKNOWN CAUSE; BLANK SCREEN, NO SOUND OR VIBRATION. 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
    303114 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1