BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3212205 · Received July 9, 2013

    Report

    Report Number
    3008382007-2013-19105
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 18, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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 ¿ (07/26/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/18/2013 AND 7/22/2013, RESPECTIVELY, 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON BETWEEN (B)(6) 2013. BETWEEN (B)(6) 2013, THE PATIENT ALLEGEDLY OBTAINED AN UNSPECIFIED A BLOOD GLUCOSE READING (WITH THE SUBJECT METER). THE PATIENT MANAGES HIS DIABETES WITH INSULIN (NOVOLOG AND BETWEEN 4-6 UNITS OF HUMALOG). ACCORDING TO THE CSR¿S DOCUMENTATION, IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT REPORTEDLY INCREASED HER HUMALOG REGIMEN AND ADMINISTERED AN ADDITIONAL 2 UNITS OF INSULIN AND SUBSEQUENTLY (BETWEEN FOUR TO FIVE HOURS LATER), THE PATIENT DEVELOPED UNSPECIFIED LOW BLOOD GLUCOSE SYMPTOMS. THE PATIENT REPORTEDLY WENT TO THE HOSPITAL AT AN UNSPECIFIED TIME LATER. ACCORDING TO THE CSR¿S DOCUMENTATION, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING (WITH THE SUBJECT METER) THAT WAS ALLEGEDLY 60-80 POINTS HIGHER COMPARED TO THE HOSPITAL¿S METER (RESULTS ARE NOT SPECIFIED), PERFORMED WITHIN 30 MINUTES FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THE PATIENT REPORTEDLY WAS ADMINISTERED (BY A HEALTH CARE PROFESSIONAL (HCP)) FOOD AND/ OR DRINK AS TREATMENT AND WAS ALLEGEDLY HOSPITALIZED FOR AN UNSPECIFIED TIME. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER¿S BOOKLET) SAMPLE SITE. 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
    313231 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3242279

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R