BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSP SS FLEXX METER

    MDR report key: 2087603 · Received May 12, 2011

    Report

    Report Number
    2939301-2011-03958
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (06/13/2011)-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.

    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

    FOLLOW-UP # 2 (06/21/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER PASSED FUNCTIONAL TESTING AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. A SECONDARY ISSUE WAS NOTED DURING VISUAL INSPECTION, THE METER'S CASING WAS FOUND CRACKED/OPENED. 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, A HEALTH CARE PROFESSIONAL/ REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE SURESTEP FLEX METERS WERE GIVING INACCURATELY HIGH READINGS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 2AM. IN THE CRITICAL CARE UNIT (CCU), AN INDIVIDUAL PATIENT WAS TESTED WITH MULTIPLE SURESTEP FLEXX METERS AND OBTAINED BLOOD GLUCOSE RESULTS BETWEEN "150-165 MG/DL." BASED ON THE HIGHER RESULTS, THE REPORTER STATED THE PATIENT WAS ADMINISTERED INSULIN (TYPE/ AMOUNT NOT SPECIFIED). THE REPORTER COULD NOT SPECIFY SYMPTOMS THE PATIENT DEVELOPED. BY 3AM THAT SAME MORNING, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "LESS THAN 20 MG/DL" FROM A LABORATORY DEVICE. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) NOTED QUALITY CONTROL TESTING HAD BEEN PERFORMED WITH PASSING RESULTS. THE TEST STRIPS WERE IN GOOD CONDITION; HOWEVER, THE REPORTER CONFIRMED THE TEST STRIPS MAY NOT HAVE BEEN STORED AND/ OR HANDLED CORRECTLY. THE REPORTER CONFIRMED THE SAME TEST STRIPS WERE BEING USED WITH THE DIFFERENT METERS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METERS, WAS ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND RECEIVED MEDICAL INTERVENTION AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R