BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 6035989 · Received October 18, 2016

    Report

    Report Number
    3008382007-2016-53628
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 10, 2016
    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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER DISPLAYED INACCURATE RESULTS COMPARED TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER CLAIMED THAT DESPITE CHANGING THE BATTERY ON HER METER ABOUT A WEEK PRIOR TO CONTACTING LFS, SHE IS CONSISTENTLY GETTING THE BATTERY INDICATOR SYMBOL TELLING HER THAT THE BATTERY IS DEAD. SHE REPORTED THAT ALSO FOR ABOUT A WEEK PRIOR TO CONTACTING LFS SHE HAD OBTAINED ALLEGED INACCURATE RESULTS OF "200, 150, 190, 186 AND 315 MG/DL" ON THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT MANAGES HER DIABETES WITH INSULIN WHICH SHE SELF-ADJUSTS. SHE REPORTED THAT AFTER OBTAINING THE ALLEGED INACCURATE RESULTS, SHE HAD CONSUMED LESS FOOD/DRINK. SHE REPORTED THAT ON (B)(6), SHE TESTED IN THE MORNING BECAUSE SHE FELT "SHAKY, HEADACHY, SWEATY, AND HAD BLURRED VISION". THE RESULT SHE OBTAINED WAS NOT PROVIDED. THE PATIENT REPORTED THAT ON (B)(6) 2016 AT 8:30 AM SHE CALLED HER DOCTOR WHO ADVISED HER TO GET 2 WEEKS OF READINGS IN ORDER TO SEE IF SHE NEEDS AN INSULIN ADJUSTMENT. SHE DENIED CHECKING HER BLOOD GLUCOSE LEVELS USING ANY OTHER DEVICE. NO OTHER TREATMENT OR MEDICAL INTERVENTION WAS SPECIFIED. DURING TROUBLESHOOTING, THE CCA ESTABLISHED THAT THE PATIENT'S TEST STRIPS WERE WITHIN EXPIRY DATE AND HAD BEEN STORED CORRECTLY AND THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. HOWEVER, THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE METER AND TEST STRIPS. THE PATIENT'S PRODUCTS WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE READINGS ON THE SUBJECT METER, ADMINISTERED LESS FOOD AND DRINK BASED ON THE ALLEGED RESULTS, 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
    688834 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3917686

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening