BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA MINI METER

    MDR report key: 12029182 · Received June 18, 2021

    Report

    Report Number
    3008382007-2021-04170
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 18, 2021
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS BEING SENT TO INCLUDE THE INVESTIGATION CONCLUSION CODE THAT WAS OMITTED FROM THE H6 FIELD OF THE INITIAL REPORT. THE INVESTIGATION CONCLUSION CODE THAT SHOULD HAVE BEEN INCLUDED AT THE TIME OF SUBMISSION OF THE INITIAL REPORT IS: 67. 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) 2021, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MSS AFTER FOLLOW-UP WITH CUSTOMER CARE. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2021 AT 11 PM. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE RESULTS OF ¿181, 353, 261 AND 211 MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿143, 135, 170, 160 AND 110 MG/DL¿ ON A TRUE METRIX METER WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT STATES THAT SHE USUALLY MANAGES HER DIABETES WITH NOVOLIN INSULIN (8 UNITS IN THE MORNING AND 10 UNITS AT NIGHT). THE PATIENT DENIED TAKING ANY ACTION WITH REGARDS TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE REPORTED ISSUE. SHE CLAIMED THAT SHE ADMINISTERED HER USUAL DOSE OF INSULIN BEFORE BED AND WENT TO SLEEP. A COUPLE OF HOURS LATER, THE PATIENT WOKE AT 2 AM ON (B)(6) 2021, WITH SYMPTOMS OF ¿SWEATING, GIBBERING, DIZZY AND BLURRY VISION¿. THE PATIENT DENIED RECEIVING ANY TREATMENT FOR THE REPORTED SYMPTOMS. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES. THE STRIPS HAD NOT BEEN OPEN LONGER THAN THE DISCARD DATE, HAD NOT EXPIRED, AND HAD BEEN STORED CORRECTLY. THE PATIENT HAD FOLLOWED THE CORRECT TESTING PROCESS. THE CCA WALKED THE REPORTER THROUGH A RETEST AND THE CONTROL SOLUTION TEST WAS NOT IN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT WHILE USING THE PRODUCT. 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
    923104 OT ULTRA MINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 4446984

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening