BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 3874761 · Received June 16, 2014

    Report

    Report Number
    2939301-2014-14549
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/15/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 8/25/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/2/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH COMPARED HER FEELINGS AND OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVES (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2014 BETWEEN ¿4:00-5:00 P. M.¿ WHEN SHE OBTAINED A BLOOD GLUCOSE READING OF ¿HIGH (33.3 MMOL/L)¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN (NOVORAPID, SELF-ADJUSTER). ON (B)(6) 2014 AT 5:00 P. M. THE PATIENT STATED SHE TOOK HER USUAL DOSE OF INSULIN (NOVORAPID, 21 UNITS) IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. IMMEDIATELY AFTER, THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿SWEATY, LIGHT HEADED, SHAKY, AND COLD¿. AT AN UNSPECIFIED TIME THAT SAME DAY, THE PATIENT STATED SHE WENT TO THE EMERGENCY ROOM (ER) AND HER BLOOD GLUCOSE WAS TESTED. THE PATIENT OBTAINED A READING OF ¿2.X MMOL/L¿ WITH THE ER/HOSPITAL METER. THE PATIENT CLAIMED SHE RECEIVED TREATMENT FROM HER HEALTH CARE PROFESSIONAL (HCP); HOWEVER, SHE COULD NOT RECALL THE TYPE OF TREATMENT RECEIVED. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AT THE TIME TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, 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
    352972 OT ULTRA TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3585610

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R