BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 7302017 · Received February 28, 2018

    Report

    Report Number
    3008382007-2018-00652
    Event Type
    Injury
    Date Received
    February 28, 2018
    Report Date
    February 21, 2018
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN ADDITION, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT HIS ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS UNABLE TO CONFIRM WHEN THE METER ISSUE BEGAN, BUT STATED IT WAS ¿AROUND (B)(6)¿. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿232, 237, 259 AND 252 MG/DL¿ WITH THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE. IN RESPONSE TO THE ALLEGED HIGH READINGS THE PATIENT REPORTED THAT SHE VISITED HER DOCTOR AND HE INCREASED HER MEDICATION. HER MEDICATION AT THE TIME OF CONTACTING LFS IS ¿GLICOSIDA 30 MG TWICE PER DAY AND METFORMIN 850 MG TWICE PER DAY¿. THE PATIENT REPORTED THAT AROUND 3 DAYS AFTER HER MEDICATION WAS INCREASED, SHE DEVELOPED SYMPTOMS OF ¿FEELING WEEK AND SOMNOLENCE¿. THERE IS NO EVIDENCE THE PATIENT RECEIVED OR REQUIRED TREATMENT FOR THE ALLEGED SYMPTOM. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, AND THAT THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY, WERE WITHIN EXPIRY DATE. THE CSR NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THERE IS INSUFFICIENT INFORMATION TO RULE OUT THE CONTRIBUTION OF THE SUBJECT METER TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146460 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4047849

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening