BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3930952 · Received July 13, 2014

    Report

    Report Number
    2939301-2014-17233
    Event Type
    Injury
    Date Received
    July 13, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 5, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT ON (B)(6) 2014 AT 7:30PM SHE OBTAINED A READING OF ¿591 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT CONFIRMED THIS RESULT WAS OBTAINED AFTER HAVING ATE SUPPER. THE PATIENT MANAGES HER DIABETES BY TAKING A SET DOSE OF LANTUS (1X/DAY) AND HUMALOG INSULIN (ADJUSTED BASED ON SLIDING SCALE). IN RESPONSE TO THE ELEVATED READING, THE PATIENT CLAIMED SHE ADMINISTERED 10 UNITS OF HUMALOG INSULIN. A COUPLE OF HOURS LATER, SHE RETESTED, OBTAINED A RESULT OF ¿396 MG/DL¿ AND TOOK AN ADDITIONAL 10 UNITS OF INSULIN. AT APPROXIMATELY 11:30PM THAT EVENING, THE PATIENT CLAIMED SHE BEGAN TO FEEL SHAKY, SWEATY, HOT AND CONFUSED; SYMPTOMS SHE ASSOCIATED WITH A LOW BLOOD SUGAR EXCURSION. THE PATIENT CONFIRMED SHE DID NOT TEST HER BLOOD GLUCOSE AT THE ONSET OF SYMPTOMS. SHE STATED SHE IMMEDIATELY BEGAN TO EAT AND DRINK WHEN SHE DIDN¿T FEEL WELL. THE PATIENT CONFIRMED SHE EVENTUALLY FELT BETTER AND THEN WENT TO SLEEP. THE FOLLOWING MORNING, WHEN SHE RETESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER SHE OBTAINED A MESSAGE OF ¿HIGH.¿ PER THE OWNER¿S BOOKLET, THE METER DISPLAYS THIS MESSAGE WHEN IT DETECTS A BLOOD GLUCOSE GREATER THAN 600 MG/DL. THE PATIENT INFORMED THE MSS THAT SHE FELT THE RESULT WAS INCORRECT AND THEREFORE RETESTED WITH ANOTHER METER SHE HAD AND OBTAINED A RESULT OF ¿220 MG/DL¿ WHICH SHE FELT WAS CORRECT. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. AT THE TIME OF TROUBLESHOOTING, THE PATIENT INFORMED THE CUSTOMER CARE ADVOCATE (CCA) THAT SHE THREW THE SUBJECT METER AFTER THE ISSUE OCCURRED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409001 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3641248

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R