BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3962155 · Received July 28, 2014

    Report

    Report Number
    2939301-2014-18820
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 11, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 3 ¿ (01/17/2015). ADDITIONAL TESTS WERE PERFORMED ON THE DESICCANT TO CHECK FOR POSSIBLE MOISTURE ISSUE. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO BE SATURATED BY MOISTURE AND FAILED TGA TESTING. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (09/22/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 7/22/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/15/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL TO CHECK THE STRUCTURAL INTEGRITY. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. 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

    FOLLOW-UP # 1 ¿ (09/04/2014). THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED. THE CONTROL SOLUTION WAS EVALUATED ON 08/28/2014 AND THE TEST STRIP EVALUATED ON 09/01/2014 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE CONTROL SOLUTION PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS GREATER THAN +50% OF THE CONTROL SOLUTION WHEN TESTED WITH CONTROL SOLUTION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH ULTRA METER IS GIVING INACCURATE HIGH READING OF ¿258 MG/DL¿ COMPARED TO THREE OTHER METER READINGS OF ¿121, 102, AND 108 MG/DL.¿ THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CA) DOCUMENTATION. THE ALLEGED READING OF ¿258 MG/DL¿ OCCURRED A FEW DAYS AGO. THE PATIENT WAS ABLE TO MANAGED HER DIABETES WITH SELF TREATMENT WITH INSULIN AND DID NOT DEVELOP ANY SYMPTOM THAT WOULD SUGGEST A SERIOUS INJURY. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THAT THE ALLEGED INACCURATE HIGH READING OF ¿258 MG/DL¿ COMPARED TO THREE OTHER METER READINGS OF ¿121, 102, AND 108 MG/DL¿ WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED INACCURATE HIGH ISSUE. THERE IS NO EVIDENCE THE PATIENT SUFFERED A SERIOUS INJURY AS SHE WAS ABLE TO MANAGE HER DIABETES WITH INSULIN BASED ON THE LFS METER READING AND DID NOT HAVE ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438115 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3475405

    Patients

    Seq Age Sex Outcome Treatment
    1