BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2913945 · Received January 14, 2013

    Report

    Report Number
    3008382007-2013-00759
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 18, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (2/20/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED 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. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT ON (B)(6) 2013. THE PATIENT REPORTED THAT BEGINNING IN (B)(6) OF 2012 HE BEGAN OBTAINING ERRATIC BLOOD GLUCOSE READING WITH THE SUBJECT METER THAT RANGED ANYWHERE FROM "125 MG/DL" TO "600 MG/DL." THE PATIENT CONFIRMED THE READINGS WERE TAKEN THROUGHOUT THE DAY. THE PATIENT INFORMED THE MSS THAT HE WAS TESTING HIS BLOOD GLUCOSE 3X/DAY AND MANAGING HIS DIABETES WITH HUMALOG 75/25 TWICE A DAY AND HUMALOG (BASED ON SLIDING SCALE). IN RESPONSE TO THE HIGHER THAN EXPECTED READINGS, THE PATIENT STATED HE CONTINUED HIS USUAL DIABETES MANAGEMENT REGIMEN, INCLUDING ADJUSTING THE AMOUNT OF NOVOLOG HE TOOK BASED ON THE METER READINGS. THE PATIENT REPORTED THAT HE HAS BEEN INTERMITTENTLY EXPERIENCING SYMPTOMS OF FEELING DIZZY, CONFUSION AND HAVING AN UPSET STOMACH. THE PATIENT REPORTED THAT A COUPLE OF DAYS BEFORE CHRISTMAS HE OBTAINED A MESSAGE OF "HI" WITH THE SUBJECT METER. PER THE OWNER'S BOOKLET, THE METER DISPLAYS THIS MESSAGE WHEN IT RECOGNIZES A BLOOD GLUCOSE READING ABOVE "600 MG/DL." THE PATIENT REPORTED THAT HE WENT TO THE ER IN RESPONSE TO THE MESSAGE AND WHEN TESTED IN THE ER, HIS BLOOD GLUCOSE WAS CONFIRMED TO BE OVER 600 MG/DL. THE PATIENT REPORTED THAT HE WAS HOSPITALIZED FOR A DAY AND WAS DIAGNOSED WITH HIGH POTASSIUM. THE PATIENT REPORTED BEING TREATED WITH INSULIN, IV FLUIDS AND MEDICATION FOR THE HIGH POTASSIUM. DURING THE FOLLOW-UP CALL, THE PATIENT ALSO REPORTED DEVELOPING SYMPTOMS OF WEAK AND SHAKY THE FIRST WEEK OF (B)(6) 2013. THE PATIENT STATED HE ASSOCIATED THE SYMPTOMS WITH A LOW BLOOD GLUCOSE AND TREATED SELF WITH FOOD AND DRINK. PRIOR TO THE ONSET OF SYMPTOMS, THE PATIENT STATED HE HAD TESTED IN THE "300 MG/DL" RANGE AND TOOK HUMALOG INSULINBASED ON THE BG READING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND THE PATIENT WAS ADVISED TO RETURN THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ALLEGED INACCURATE HIGH READING WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20407 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3336168

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R