BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2080765 · Received May 6, 2011

    Report

    Report Number
    2939301-2011-03759
    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 (06/07/2011)-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 BETWEEN 2:09PM AND 2:15PM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "365 AND 359 MG/DL" WITH THE SUBJECT METER AND "20 MG/DL" ON ANOTHER METER (EMERGENCY MEDICAL SERVICES METER), PERFORMED GREATER THAN 30 MINUTES OF EACH OTHER. 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 AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT STATED SHE BEGAN TO FEEL SWEATY AND WAS UNRESPONSIVE. IN RESPONSE TO HER SYMPTOMS, THE PATIENT CLARIFIED AND CONFIRMED SHE LAID DOWN AND RESTED. WHEN HER NURSE ARRIVED LATER THAT EVENING, THE PATIENT STATED SHE TESTED AGAIN WITH THE SUBJECT METER AND OBTAINED A READING OF "287 MG/DL" AT 6:01PM. SINCE THE SUBJECT METER INDICATED ANOTHER HIGH READING, THE PATIENT STATED SHE TESTED ON HER OTHER ONETOUCH ULTRAMINI METER AND OBTAINED READINGS OF "321 AND 279 MG/DL" AT 6:06PM. ACCORDING TO THE PATIENT, SINCE THE READINGS WERE HIGH ON BOTH METERS, THE NURSE ADMINISTERED INSULIN; HOWEVER SHE WAS NOT ABLE RECALL THE TYPE/DOSE TAKEN. 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, REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY REQUIRING 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