BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 6036033 · Received October 18, 2016

    Report

    Report Number
    3008382007-2016-53673
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 10, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. THIS SUPPLEMENTAL IS BEING SENT TO CORRECT INFORMATION PREVIOUSLY SUBMITTED. THE ALERT DATE OF FOLLOW-UP # 1 SHOULD HAVE STATED (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) 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 CLAIMED THAT THE SUBJECT METER STARTED TO READ INACCURATELY DURING THE EVENING OF (B)(6) 2016 WHEN SHE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS OF "180, 244, 194, 149, 301, 209, 158 AND 193MG/DL". METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT MANAGES HER DIABETES WITH INSULIN WHICH SHE SELF-ADJUSTS. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AFTER OBTAINING THE ALLEGED INACCURATE HIGH RESULTS. SHE REPORTED THAT ABOUT 3 HOUR LATER, SHE DEVELOPED SYMPTOMS OF "NAUSEA AND SWEATS" SHE DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THAT HER TEST STRIPS WERE WITHIN EXPIRY DATE AND HAD BEEN STORED CORRECTLY AND HER METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE METER AND TEST STRIPS. THE PATIENT'S PRODUCTS WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH RESULTS WITH THE SUBJECT METER, ADMINISTERED MEDICATION BASED ON THE RESULTS AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688071 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3988300

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening