BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3954341 · Received July 24, 2014

    Report

    Report Number
    2939301-2014-18407
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 16, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (10/15/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 9/4/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/6/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONE TOUCH PING METER READ INACCURATELY LOW WITH THE CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT AN ALLEGED INACCURACY BEGAN ON (B)(6) 2014 AT 3:00 P. M. AT AN UNSPECIFIED DATE/TIME THE PATIENT OBTAINED A CONTROL SOLUTION RESULT OF "70 SOMETHING (117-156) MG/DL" WITH THE SUBJECT METER, WHICH FELL BELOW THE CONTROL SOLUTION RANGE PRINTED ON THE VIAL OF TEST STRIPS. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP AND DENIED TAKING ANY ACTION IN REGARDS TO HER NORMAL DIABETES MANAGEMENT IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT STATED "LESS THAN 10 MINUTES" AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF "CONFUSED, COULDN'T WALK, AND WEAK". ON (B)(6) 2014 AT 7:00 P. M. THE PATIENT STATED SHE SELF-TREATED WITH FOOD AND/OR DRINK IN RESPONSE TO THE SYMPTOMS. AT 7:20 P. M. THAT SAME DAY, THE PATIENT MENTIONED SHE TESTED HER BLOOD GLUCOSE ON ANOTHER DEVICE (TRUE 2 GO); HOWEVER, SHE DID NOT PROVIDE THE ACTUAL RESULTS OBTAINED AT THE TIME. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT TREATED HERSELF WITH FOOD AND/OR DRINK, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENTS REPORTED SYMPTOMS DO NOT MEET LFS CRITERIA OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434605 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3422747

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR