BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 7376542 · Received March 28, 2018

    Report

    Report Number
    3008382007-2018-00930
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    March 15, 2018
    Report Date
    March 19, 2018
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. LIFESCAN ALSO CONDUCTED AN EVALUATION OF THE TEST STRIP LOT AND CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED. 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) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT AT 7:35 AM ON (B)(6) 2018, SHE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS OF ¿191, 250 AND 196 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 A COMBINATION OF INSULIN AND ORAL MEDICATIONS. SHE REPORTED THAT AFTER OBTAINING THE ALLEGED INACCURATE HIGH RESULTS, SHE HAD EATEN LESS FOOD/DRINK TO ¿COUNTER THE HIGH READINGS¿. SHE REPORTED THAT LATER, SHE DEVELOPED MILD HEADACHES, AND ON (B)(6) 2018, SHE HAD A ¿BAD HEADACHE¿ WHICH SHE SELF-TREATED BY TAKING TWO TYLENOL TABLETS. SHE DENIED USING ANY OTHER DEVICE TO TEST HER BLOOD GLUCOSE LEVELS. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THAT HER METER WAS SET TO THE CORRECT UNIT OF MEASURE AND HER TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE WITHIN EXPIRY DATE. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE METER AND TEST STRIPS. REPLACEMENT PRODUCTS, INCLUDING CONTROL SOLUTION, WERE SENT TO THE PATIENT AND SHE WAS ADVISED TO CALL-BACK TO WALK THROUGH A CONTROL SOLUTION TEST WHEN THE PRODUCTS ARRIVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT, I.E. A BAD HEADACHE, AFTER OBTAINING ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS ON THE SUBJECT METER AND CONSUMING LESS FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223107 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4310418 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R