BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2920768 · Received January 17, 2013

    Report

    Report Number
    3008382007-2013-01065
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 21, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (02/14/2013)-DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2013 AND (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS WERE TESTED ADN BOTH PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN AFTER THANKSGIVING (DATE/TIME NOT SPECIFIED). ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS IN THE 300'S WITH THE SUBJECT METER AND "190MG/DL" WITH THE BAYER METER, 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. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN; HOWEVER, ACCORDING TO THE CSR'S DOCUMENTATION THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER) AND IN RESPONSE TO THE ALLEGED METER ISSUE THE PATIENT REPORTEDLY ADMINISTERED AN UNSPECIFIED DOSE OF HUMALOG INSULIN AT AN UNKNOWN DATE/ TIME LATER. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED METER ISSUE THE PATIENT REPORTEDLY DEVELOPED UNSPECIFIED SYMPTOMS OF "LOW BLOOD SUGAR, HIGH BLOOD SUGAR" APPROXIMATELY TWO DAYS LATER. THE PATIENT'S BLOOD GLUCOSE READING(S) PRIOR TO AND AT THE ONSET OF THE SYMPTOM(S) IS NOT KNOWN. THE PATIENT DENIED RECEIVING TREATMENT AFTER THE ALLEGED METER ISSUE BEGAN. 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. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT'S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY SUFFERED SYMPTOMS INDICATIVE OF A SERIOUS INJURY WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25952 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3377629

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening