BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3606006 · Received February 4, 2014

    Report

    Report Number
    2939301-2014-02459
    Event Type
    Injury
    Date Received
    February 4, 2014
    Report Date
    January 29, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 HIS ONE TOUCH ULTRA 2 METER READ INACCURATELY WHEN PERFORMING CONSECUTIVE BLOOD GLUCOSE TESTS AND WHEN COMPARED TO HIS FEELINGS AND OR NORMAL RESULTS. 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)(4) 2014. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY STARTED ON (B)(6) 2014 AT 5:05 P.M. WHEN HE OBTAINED BLOOD GLUCOSE RESULTS OF ¿99, 167 MG/DL¿ WITH THE SUBJECT METER, PERFORMED GREATER THAN 20 MINUTES FROM EACH OTHER. ON (B)(6) 2014 AT 8:20 A. M., THE PATIENT STATED HE OBTAINED BLOOD GLUCOSE RESULTS OF ¿188, 203, 168, 211 MG/DL¿ WITH THE SUBJECT METER, PERFORMED GREATER THAN 20 MINUTES FROM EACH OTHER. ON (B)(6) 2014 AT 7:10 A. M., THE PATIENT STATED HE OBTAINED BLOOD GLUCOSE RESULT OF ¿180, 192 MG/DL¿ WITH THE SUBJECT METER, PERFORMED GREATER THAN 20 MINUTES FROM EACH OTHER. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN, 500 MG IN THE MORNING AND 1000 MG AT NIGHT; GLYBURIDE, 5 MG IN THE MORNING AND AT NIGHT), DIET, AND EXERCISE. ON (B)(6) 2014 AT 4:00 P. M. THE PATIENT CONTACTED HIS DOCTOR AND WAS ADVISED TO ¿INCREASE METFORMIN TO 1000 MG IN THE MORNING¿. THE PATIENT TOOK AN INCREASED DOSE OF MEDICATION (METFORMIN, 1000 MG) IN RESPONSE TO THE ALLEGED INACCURATE RESULT(S). THE PATIENT REPORTED, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS OF ¿SHAKY, DIZZY, SLEEPY, HEARTBEAT AND SWEATY¿. THE PATIENT SELF-TREATED WITH GATORADE AND CONFIRMED HE BEGAN TO FEEL BETTER, 2-3 MINUTES AFTERWARDS. AT THE TIME OF THE FOLLOW-UP CALL, THE PATIENT STATED THAT HE TESTS HIS BLOOD GLUCOSE 3 TIMES A DAY AND THAT HIS NORMAL/TYPICAL BLOOD GLUCOSE READINGS RANGE FROM ¿120-140 MG/DL¿ IN THE MORNING, ¿90 MG/DL¿ IN THE AFTERNOON, AND ¿80-90 MG/DL¿ IN THE EVENING. THE PATIENT ALLEGED THE SUBJECT METER WAS READING INACCURATELY HIGH WHEN COMPARED TO HIS FEELINGS AND OR NORMAL RESULTS. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED INACCURATE HIGH/ERRATIC READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT(S), 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
    72347 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3547252

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R