BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSP SS FLEXX METER LASER

    MDR report key: 2132655 · Received June 17, 2011

    Report

    Report Number
    2939301-2011-04949
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 26, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 K023832.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE NOT BEEN RETURNED TO LIFESCAN FOR PRODUCT ANALYSIS. THE RETAIN TEST STRIPS WERE TESTED AND THEY 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, LIFESCAN RECEIVED A MEDWATCH NOTIFICATION FOR THE FDA. REPORTEDLY, THE PATIENT ARRIVED AT THE CRITICAL CARE UNIT AT 11 AM (UNSPECIFIED DATE) AND RECEIVED IV INSULIN TREATMENT BASED ON THE LIFESCAN METER READINGS. THE PATIENT'S BLOOD GLUCOSE WAS TESTED AT "303, 487, AND 519 MG/DL" AT 11 AM, 12 PM, AND 1 PM RESPECTIVELY. AS PER THE HOSPITAL'S PROTOCOL, THE NURSE SENT THE PATIENT'S BLOOD TO THE LAB TO CONFIRM THE CRITICAL HIGH OF "519 MG/DL." THE LAB RESULTS CAME BACK WITH A BLOOD GLUCOSE READING OF "294 MG/DL." FURTHER CORRELATION TEST WERE PERFORM BETWEEN THE LFS METER AND LAB. AT 2 PM THE LFS METER READ "429 MG/DL" WHILE THE LAB RESULT WAS "183 MG/DL." THE REPORTER INDICATED THAT THE PATIENT'S BLOOD GLUCOSE WENT LOWER THAN NORMAL DUE TO THE INSULIN TREATMENT BASED ON THE ALLEGED INACCURATE HIGH RESULTS ON THE LFS METER. A NEW VIAL OF TEST STRIPS WAS OPENED AT THE TIME OF CONCERN. THE REPORTER INDICATED THAT THE QUALITY CONTROL TEST PASSED FOR BOTH HIGH AND LOW. THE ACCURACY WAS ACCEPTABLE WITH THE NEW VIAL OF TEST STRIPS. ON (B)(6) 2011, THIS MEDICAL SURVEILLANCE SPECIAL CONTACTED THE REPORTER TO ASSESSMENT THE SEVERITY OF THE PATIENT'S LOW BLOOD GLUCOSE. ACCORDING TO THE REPORTER, THE PATIENT "WAS HYPOGLYCEMIC." THE REPORTER COULD NOT PROVIDE THE PATIENT'S BLOOD GLUCOSE OR THE SYMPTOMS AT THE TIME OF CONCERN. BASED ON THE REPORTED LFS METER READING TO LAB COMPARISON, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY WAS HYPOGLYCEMIC AFTER THE HE RECEIVED IV INSULIN TREATMENT PER THE ELEVATED LFS READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSP SS FLEXX METER LASER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3063325004

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R