BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3221326 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10334
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS REQUESTED THE SUBJECT PRODUCTS TO BE RETURNED FOR EVALUATION HOWEVER THE PRODUCTS HAVE NOT YET BEEN RETURNED OR EVALUATED. IF ANIMAS RECEIVES THE PRODUCT ANIMAS WILL INFORM THE FDA OF ANY PRODUCTS THAT FAIL EVALUATION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1 DATE OF SUBMISSION 09/18/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/29/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL. UNRELATED TO INITIAL COMPLAINT, MULTIPLE CRACKS WERE OBSERVED IN THE BATTERY COMPARTMENT AT OPENING OF BATTERY CHAMBER EXTENDING DOWN TO THE PRIMARY SEAL. THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN UNTIL O-RING WAS SEATED AND CAP WAS FLUSH WITH THE PUMP CASE. NO ISSUE WITH LOSS OF POWER OBSERVED. NO EVIDENCE OF MOISTURE DAMAGE IN BATTERY COMPARTMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THE REPORTER ALLEGED THAT THE PUMP SCREEN HAD SCRATCHES AND THE LETTERING IS DIFFERENT COLORS. 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
    319919 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR