BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2080767 · Received May 6, 2011

    Report

    Report Number
    2939301-2011-03760
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. 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. 510(K) # IS K061118.

    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 HIGH COMPARED TO ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6) 2011 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HER TESTING FREQUENCY IS 5 TIMES DAILY AND MANAGES HER DIABETES WITH LANTUS AND NOVOLOG INSULIN. THE PATIENT CONFIRMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 6:06PM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "279 AND 321 MG/DL" WITH THE SUBJECT METER AND "20 MG/DL" ON ANOTHER METER (EMERGENCY MEDICAL SERVICE METER), PERFORMED WITH 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. DUE TO THE ALLEGED READINGS, THE PATIENT INDICATED HER NURSE ADMINISTERED AN UNSPECIFIED TYPE/DOSE OF INSULIN. PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "365 AND 359 MG/DL" ON ANOTHER ONETOUCH ULTRAMINI METER BETWEEN 2:09PM AND 2:15PM EARLIER THAT DAY. AFTER OBTAINING THE ALLEGED READING OF "359 MG/DL", THE PATIENT STATED SHE ADMINISTERED 3 UNITS OF NOVOLOG INSULIN. BY 3:03PM LATER THAT DAY, THE PATIENT CONFIRMED SHE TESTED AGAIN ON THE SUBJECT METER WITH A RESULT OF "235 MG/DL", THEN ADMINISTERED ANOTHER 2 UNITS OF NOVOLOG INSULIN. MORE THAN AN HOUR LATER, THE PATIENT STATED SHE BEGAN TO FEEL SWEATY AND WAS UNRESPONSIVE. IN RESPONSE TO HER SYMPTOMS, THE PATIENT STATED SHE LAID DOWN AND RESTED. AT APPROXIMATELY 6:15PM THAT EVENING, THE PATIENT STATED EMERGENCY MEDICAL SERVICES (EMS) WAS NOTIFIED FOR ASSISTANCE. WHEN THE EMS ARRIVED, THE PATIENT CONFIRMED SHE WAS TESTED BY THE EMS METER WITH THE READING OF "20 MG/DL" AND WAS IMMEDIATELY ADMINISTERED IV GLUCOSE. AN HOUR AFTER HER TREATMENT, THE PATIENT CONFIRMED SHE FELT BETTER AND ATE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULTS FROM THE SUBJECT METER, THE PATIENT'S TESTING PROCEDURE WAS CORRECT, AND THE METER'S UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY RECEIVED HCP INTERVENTION 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. 3067392

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R