BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 7230063 · Received January 31, 2018

    Report

    Report Number
    3008382007-2018-00352
    Event Type
    Injury
    Date Received
    January 31, 2018
    Report Date
    January 26, 2018
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008136
    PMA / PMN Number
    K061118
    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. 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. 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 ULTRAMINI 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 STARTING AT 1PM ON (B)(6) 2017, SHE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS OF ¿182, 240, 159, 194, 222 AND 191 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 ORAL MEDICATION OF METFORMIN AND GLIMEPIRIDE. SHE INDICATED THAT AFTER OBTAINING THE ALLEGED HIGH RESULTS, SHE TOOK EXERCISE. SHE STATED THAT ON AN UNKNOWN DATE AND TIME, SHE DEVELOPED SYMPTOMS OF ¿SWEATING AND WEAKNESS¿. NO TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT WAS REPORTED; HOWEVER, SHE INDICATED THAT DURING A DOCTOR¿S OFFICE VISIT ON (B)(6) 2018, SHE WAS PRESCRIBED ORAL MEDICATION OF JANUVIA 100MG, ONCE PER DAY. 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 TEST TO TEST THE METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT, I.E. SWEATING AND WEAKNESS, WHILE USING THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75452 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4237551 00353885008136

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening