BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5112821 · Received September 30, 2015

    Report

    Report Number
    2939301-2015-41290
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    September 28, 2015
    Report Date
    September 21, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    FOLLOW-UP # 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.

    Additional Manufacturer Narrative · 1

    THE METER 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) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING INACCURATE HIGH COMPARISONS PERFORMED ON HER ONETOUCH ULTRA2 METER COMPARED TO BOTH HER FEELINGS/NORMAL RESULTS AND TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE METER STARTED READING INACCURATELY COMPARED TO HER FEELINGS AT APPROXIMATELY 9-10PM ON (B)(6) 2015 ALTHOUGH NO RESULTS WERE PROVIDED FOR THIS TIME. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). SHE REPORTED THAT ALSO AT APPROXIMATELY 9-10PM ON (B)(6) 2015, SHE ADMINISTERED HER USUAL DOSE OF HUMALOG INSULIN, INCLUDING SLIDING SCALE. SHE CLAIMED THAT APPROXIMATELY 5 HOURS AFTER THE START OF THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS OF "SHAKY [AND] NO VISION". SHE ALSO CLAIMED THAT AT 2:00AM ON (B)(6) 2015, SHE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS OF "218, 172, 207, 183, 203 AND 197 MG/DL" ON THE SUBJECT METER, COMPARED TO "35 MG/DL" ON ANOTHER ONETOUCH ULTRA2METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THESE RESULTS FALLS OUTSIDE LFS' ACCURACY CRITERIA. SHE REPORTED THAT ALSO AT 2:00AM ON (B)(6) 2015, SHE SELF-ADMINISTERED "GLUCOSE TABLETS/GLUCOSE GELL" TO TREAT HER SYMPTOMS. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT'S METER WAS SET TO THE CORRECT UNIT OF MEASURE, SHE HAD USED AN APPROVED SAMPLE SITE AND THE CORRECT TESTING TECHNIQUE. THE CCA ALSO NOTED THAT THE PATIENT'S TEST STRIPS HAD BEEN STORED CORRECTLY AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. HOWEVER, THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE WITH WHICH TO TEST THE METER AND TEST STRIPS AND THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY OBTAINED INACCURATELY HIGH RESULTS WITH THE SUBJECT METER, ADMINISTERED MEDICATION BASED ON THE RESULTS AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643829 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3831483

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening| R