BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4171781 · Received October 15, 2014

    Report

    Report Number
    2939301-2014-27433
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    October 6, 2014
    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
    IL, 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 WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER REVIEWING THE CALL RECORDING. THE PATIENT REPORTED THAT SHE BEGAN TO OBTAIN THE INACCURATE HIGH RESULTS WITH THE SUBJECT METER APPROXIMATELY 1 ½ WEEKS PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE CUSTOMER CARE ADVOCATE (CCA) THAT SHE IS SUFFERS FROM HYPOGLYCEMIA AND HER BLOOD SUGAR READINGS ARE USUALLY BETWEEN ¿40 AND 60 MG/DL¿. THE PATIENT REPORTED OBTAINING INACCURATE HIGH READINGS OF ¿150, 212, 380 AND 412 MG/DL¿ ON UNSPECIFIED DATES. THE PATIENT STATED IN RESPONSE TO THE ELEVATED RESULTS SHE ATE LESS FOOD. THE PATIENT CONFIRMED THAT SHE DOES NOT TAKE ANY MEDICATIONS TO MANAGE HER MEDICAL CONDITION. THREE DAYS (DATE NOT PROVIDED) AFTER SHE BEGAN TO OBTAIN WHAT SHE FELT WERE INACCURATE HIGH READINGS WITH THE SUBJECT METER, THE PATIENT STATED SHE WENT TO THE ER BECAUSE SHE THOUGHT HER BLOOD GLUCOSE WAS TOO HIGH; HOWEVER, DURING THE ER VISIT THEY DISCOVERED HER BLOOD SUGAR WAS TOO LOW. THE PATIENT CONFIRMED HER BLOOD GLUCOSE WAS TESTED WITH ANOTHER DEVICE DURING ER VISIT, BUT THAT RESULT WAS NOT PROVIDED. THE PATIENT STATED SHE WAS TREATED WITH GLUCOSE TABLETS TO GET HER BLOOD GLUCOSE LEVELS BACK UP. AT THE TIME OF THE TROUBLESHOOTING, THE PATIENT INFORMED THE CCA SHE DID NOT HAVE THE SUBJECT METER OR TESTING SUPPLIES WITH HER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER OBTAINING ALLEGED INACCURATE HIGH RESULTS WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654768 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R