BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3962054 · Received July 28, 2014

    Report

    Report Number
    2939301-2014-18819
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 22, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (08/28/2014). THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED AND THE TEST STRIPS WEERE EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 08/26/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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 # 1 ¿ (08/19/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO HER FEELING/NORMAL RESULT(S). THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN THE BEGINNING OF (B)(6). AT AN UNSPECIFIED DATE/TIME, THE PATIENT OBTAINED A BLOOD GLUCOSE READING IN THE 200¿S. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY; HOWEVER, IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK FOLLOWING THE REPORTED METER ISSUE. ACCORDING TO THE CSR¿S DOCUMENTATION, 20 MINUTES AFTER THE ALLEGED METER ISSUE FIRST BEGAN THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SWEATING AND BLURRY VISION; THE PATIENT¿S TREATMENT AFTER THE ONSET OF HER SYMPTOMS, HOWEVER, IS NOT CLEAR. FOR AN UNSPECIFIED REASON, ON (B)(6) 2014 (AT 7:05AM), THE PATIENT REPORTED CONSUMING MORE FOOD/DRINK. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438256 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3512698

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening