BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2031856 · Received March 28, 2011

    Report

    Report Number
    2939301-2011-02648
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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. 510(K) # IS K061118.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/05/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER DISPLAYED AN "ER 5" MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE ALLEGED ISSUE BEGAN ABOUT 4 MONTHS AGO PRIOR TO CONTACTING LFS. THE MSS WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH HUMULIN R INSULIN AND LANTUS INSULIN. THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATIONS. ON THE EVENING OF (B)(6) 2011, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SHAKY, "DRUNK LIKE," SLURRED SPEECH, AND PASSED OUT. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "42 AND 32 MG/DL" WITH THE EMS METER. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE AS TREATMENT. THE PATIENT STATED SHE FELT BETTER AFTER AND OBTAINED A BLOOD GLUCOSE RESULT OF "110 MG/DL." THE PATIENT CONFIRMED SHE DID NOT HAVE ANOTHER METER TO TEST WITH AT THAT TIME. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) TRIED TO WALK THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3079617

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R