BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3212620 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-09931
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 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: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED DURING INVESTIGATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE ALL BUTTONS WERE RESPONSIVE. THERE WAS NO EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE KEY CONTACTS. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/20/2013 WITH THE FOLLOWING FINDINGS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE METER WAS NOT RETURNED WITH THE PUMP. NO INSULIN DELIVERY DEFECT WAS FOUND. THE BLACK BOX BEGINS ON (B)(6) 2013. PUMP HISTORY AND BLACK BOX FOR EVENT ON (B)(6) 2012 HAS BEEN OVERWRITTEN. PUMP I:C RATIO WAS SET TO 1U:10G FOR THE INVESTIGATION. RETURNED PUMP WAS SUCCESSFULLY PAIRED WITH TEST METER. THE TEST METER CORRECTLY SHOWED THE SAME I:C RATIO AS THE PUMP. PERFORMED A EZCARB BOLUS FROM THE TEST METER USING 50G CARBS; TEST METER SHOWED CORRECT CALCULATION OF 5.00U(SEE ATTACHED PHOTOS OF TEST METER).. UNITS REMAINING WERE CORRECTLY CALCULATED IN STEPS 17 THROUGH 20 AND WRITTEN TO THE PUMP HISTORY. PUMP SUCCESSFULLY PASSED A 29HR FLOW ACCURACY TEST ((B)(4)). UNRELATED TO THE COMPLAINT, THE DISPLAY HAS A PINKISH CONTRAST. REMOVED COVER AND REPLACED PINK DISPLAY WITH TEST DISPLAY. THE TEST SCREEN IS FULLY ILLUMINATED WITH NO VISIBLE SIGNS OF DISCOLORATION. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S FATHER CONTACTED ANIMAS REPORTING THAT THE KEYPAD TO THEIR PUMP WAS COMPLETELY UNRESPONSIVE. THIS EVENT OCCURED AFTER THE PATIENT HAD REMOVED THE BATTERY MULTIPLE TIMES IN AN ATTEMPT TO CLEAR AN ALARM. 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
    312962 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR