BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA 2 METER

    MDR report key: 10747578 · Received October 28, 2020

    Report

    Report Number
    3008382007-2020-04029
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 8, 2020
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED PERFORMANCE 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. SIMILAR COMPLAINTS FOR THIS ISSUE WERE TRENDED INCLUDING THE REPORTED METER. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE METER DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE. IN ADDITION, SIMILAR COMPLAINTS FOR THIS ISSUE WERE TRENDED FOR THE TEST STRIP LOT. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE LOT DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE. 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) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (TRUE METRIX). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN ON (B)(6) 2020. THE PATIENT REPORTED OBTAINING READINGS OF "120, 287, 139, 153, 221 AND 135 MG/DL" WITH THE SUBJECT METER AND "102, 245, 83, 129, 197 AND 108 MG/DL" RESPECTIVELY ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN TAKEN 4 TIMES A DAY AND THAT AS A RESULT OF THE ALLEGED ISSUE, SHE CUT OUT SNACKS FROM HER DIET. THE PATIENT REPORTED THAT ON (B)(6) 2020 AT AROUND 4:00 PM, SHE OBTAINED A RESULT OF "84 MG/DL" WITH THE SUBJECT METER AND STARTED "SHAKING." THE PATIENT INDICATED THAT SHE NORMALLY BECOMES SYMPTOMATIC FOR HYPOGLYCEMIA WHEN HER BLOOD GLUCOSE FALLS BELOW 60 MG/DL. THE PATIENT CLAIMED SHE TOOK A DRINK WITH SUGAR AS SELF-TREATMENT FOR THE SYMPTOM, RESTED AND FELT BETTER AFTER. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING AND THAT THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECT AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED INACCURACY ISSUE BEGAN. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213064 OT ULTRA 2 METER GLUOCSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 021-105 4642062 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R