BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3061207 · Received April 16, 2013

    Report

    Report Number
    3008382007-2013-08020
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 18, 2013
    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
    CA, 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) 2013, THE LAY USER/PATIENT'S RELATIVE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER CLAIMED THE ALLEGED METER INACCURACY BEGAN ON THE MORNING OF (B)(6) 2013. THE PATIENT'S RELATIVE REPORTED THAT THE PATIENT OBTAINED ALLEGED INACCURATE HIGH READINGS OF "225, 235, 263, 232, 261, 228, 215 AND 235 MG/DL" WITH THE SUBJECT METER ON UNSPECIFIED DATES AND TIMES. THE REPORTER STATED THE READINGS OBTAINED WITH THE SUBJECT METER WERE HIGHER COMPARED TO RESULTS OF "173, 199, 138, 205, 113 AND 143 MG/DL" OBTAINED ON ANOTHER DEVICE. THE REPORTER CONFIRMED THAT MORE THAN 30 MINUTES ELAPSED BETWEEN THE METER READINGS ON BOTH DEVICES. THE PATIENT MANAGES HER DIABETES WITH INSULIN. IT IS NOT KNOWN IF THE PATIENT ADJUSTED HER INSULIN DOSE BASED ON A METER RESULT. THE REPORTER CLAIMED THAT 1 HOUR AFTER OBTAINING AN ALLEGED INACCURATE HIGH READING WITH THE SUBJECT METER ON (B)(6) 2013 AT 7AM SHE DEVELOPED SYMPTOMS OF "SWEATING, RACING HEART, AND FEELING WEAK". THE REPORTER CLAIMED THE PATIENT TREATED HERSELF WITH FOOD AND/OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE REPORTER DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. THE SUBJECT METER AND TEST STRIPS WERE REQUESTED TO BE RETURNED. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ALLEGED INACCURATE HIGH RESULT WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163838 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3417488

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R