BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2250739 · Received September 16, 2011

    Report

    Report Number
    2939301-2011-09134
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 24, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ((B)(4) 2011): THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN (LFS) PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED WITH NO FAULTS FOUND. THE METER HAS ALSO BEEN RETURNED TO LFS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. THE 510(K) # IS K061118.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (10/12/2011)-DEVICE EVALUATION: THE PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (PA DATE TESTING COMPLETED) 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 THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 3 AM. THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "147, 133, 123, 154, 120, 95, 122, 124MG/DL" WITH THE SUBJECT METER, PERFORMED MORE THAN 20 MINUTES OF EACH OTHER (DATES/TIMES NOT SPECIFIED). THE PATIENT'S TESTING FREQUENCY AND USUAL BLOOD GLUCOSE RANGE ARE NOT KNOWN AND THE REASON THE PATIENT WAS TESTING AT 3 AM IS NOT SPECIFIED. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED SHE ALSO MANAGES HER DIABETES WITH DIET AND/OR EXERCISE; HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF EXTREME THIRST AND URINATION APPROXIMATELY 6 ½ HOURS LATER. THE PATIENT'S BLOOD GLUCOSE RESULT PRIOR TO AND/OR AT THE ONSET OF HER REPORTED SYMPTOMS ARE NOT KNOWN. THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION/ TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S MANUAL) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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. 3155504

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening