BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1891407 · Received November 4, 2010

    Report

    Report Number
    2939301-2010-09681
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    October 13, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 510(K) # IS K061118. (B)(6) 2010: THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT'S FAMILY MEMBER CONTACTED LIFESCAN (LFS) ALLEGING THAT RESULTS WERE MISSING FROM THE PATIENT'S ONETOUCH ULTRAMINI METER. 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 REPORTER ALLEGED THE ISSUE BEGAN IN THE EVENING OF (B)(6) (YEAR NOT SPECIFIED). ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HIS DIABETES WITH AN UNKNOWN TYPE OF INSULIN (NO ADJUSTMENTS); PATIENT'S TESTING AND MEDICATION FREQUENCY ARE NOT SPECIFIED. THE REPORTER DENIED THAT THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. IT IS NOT KNOWN IF THE PATIENT CONTINUED TO TEST WITH THE SUBJECT METER (BLOOD GLUCOSE RESULTS WERE NOT SPECIFIED) AND IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE BLOOD GLUCOSE RESULTS WITH THE SUBJECT METER. THE REPORTER DENIED THAT THE PATIENT TESTED WITH ANOTHER DEVICE. APPROXIMATELY 1 1/2 MONTHS AFTER THE ALLEGED ISSUE BEGAN, THE REPORTER CLAIMED THE PATIENT EXPERIENCED SYMPTOMS OF SHAKING, WEAKNESS IN LEGS, AND THIRST; HOWEVER, IT IS NOT KNOWN WHAT THE PATIENT'S SPECIFIC BLOOD GLUCOSE RESULTS WERE PRIOR TO THE ONSET OR DURING HIS SYMPTOMS. THE REPORTER INDICATED THE PATIENT ADMINISTERED SELF-TREATMENT; TYPE OF TREATMENT AND DATE/TIME OF TREATMENT ARE UNKNOWN. IT IS ALSO NOT SPECIFIED IF THE PATIENT'S REPORTED SYMPTOMS PROGRESSED OR WHEN THE SYMPTOMS DETERIORATED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THERE WAS NO MISUSE OF THE LFS PRODUCT AND THE PATIENT WAS NOT USING THE METER FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. RESULTS MISSING FROM THE METER'S MEMORY WOULD NOT HAVE PRECLUDED THE PATIENT FROM OBTAINING ACTIONABLE BLOOD GLUCOSE RESULTS. THE PATIENT ALLEGEDLY EXPERIENCED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE KEYPAD HAS BEEN INTERMITTENTLY UNRESPONSIVE OVER THE PAST WEEK. THE PT REPORTS HAVING TO PRESS THE BUTTONS MULTIPLE TIMES TO ELICIT A RESPONSE. PUMP WAS NOT EXPOSED TO MOISTURE AND THE KEYPAD IS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2850088

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening