BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 4191626 · Received October 22, 2014

    Report

    Report Number
    2939301-2014-28193
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 17, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/24/2015 DEVICE EVALUATION. THE LAY USER/PATIENTS METER HAS BEEN RETURNED ON 10/30/2014 AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/8/2015 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 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, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRALINK METER READ INACCURATELY HIGH IN COMPARISON TO ANOTHER METER (ONETOUCH ULTRAMINI). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER CLAIMED THAT ON (B)(6) 2014, AT 12:00PM THE PATIENT OBTAINED RESULTS OF ¿373MG/DL AND 434MG/DL¿ ON THE SUBJECT METER WHICH SHE FELT WERE HIGH IN COMPARISON TO A RESULT OF ¿135MG/DL¿ OBTAINED ON (B)(6) 2014, AT 12:20PM, ON A ONETOUCH ULTRAMINI METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE REPORTER DETAILED THAT THE PATIENT MANAGES HER DIABETES USING AN INSULIN PUMP AND THAT SHE CONTINUED TO TAKE HER USUAL DOSE OF MEDICATION IN RESPONSE TO THE ALLEGED INACCURACY. THE REPORTER CLAIMED THAT THE PATIENT CONSUMED FOOD OR DRINK AT 12:20PM ON (B)(6) 2014 AND DENIED THAT THE PATIENT DEVELOPED ANY SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNITS OF MEASURE AND THAT AN APPROVED SAMPLE SITE HAD BEEN USED. THE REPORTER DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A CONTROL SOLUTION TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE PRODUCT ISSUE CAUSED AND/OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT DID NOT DEVELOP SIGNS OR SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL TREATMENT FROM A HEALTHCARE PROFESSIONAL FOR EITHER OF THESE CONDITIONS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673201 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3552360

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR