BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN2IT (I) A1C TEST CARTRIDGES

    MDR report key: 1833780 · Received September 9, 2010

    Report

    Report Number
    8043550-2010-00001
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BIO-RAD LABORATORIES DEESIDE
    Product Code
    LCP
    PMA / PMN Number
    K041635
    Removal / Correction Number
    8043550-07/26/2010-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINTS WERE RECEIVED BY BIO-RAD (B)(4) SUBSIDIARY WITH REPORTS OF HIGH BIAS RESULTS. ON THE BASIS OF THESE COMPLAINTS AND BECAUSE THERE WERE NO CLAIMS OF PRODUCT LIMITATIONS RELATING TO ALTITUDE, BIO-RAD MADE THE DECISION ON 07/15 TO IMPLEMENT A MEDICAL DEVICE CORRECTION AND CUSTOMER NOTIFICATION. THE FDA REPRESENTATIVE WAS NOTIFIED BY EMAIL OF THE PROPOSED RECALL ON 07/14/2010. ON 07/23, TWO POTENTIAL CASES OF HYPOGLYCEMIA WERE REPORTED AS A RESULT OF INCORRECT INSULIN TREATMENT. THE COURSE OF ACTION REMAINED UNCHANGED, WITH THE RECALL SCHEDULED TO BE INITIATED THE NEXT WORKING DAY. THE INTERNAL INVESTIGATION WAS REVEALED THAT THE PROBLEM WAS SPECIFICALLY ASSOCIATED WITH ELEVATED ALTITUDES AND THAT ALL PRODUCTS ARE AT RISK IF RUN AT >1,000M (3280 FEET). THE CUSTOMER SITES THAT REPORTED THE COMPLAINT WERE RUNNING TESTS AT ELEVATIONS OF >1600M (5250 FEET). ROOT CAUSE: WHEN PERFORMING IN2IT TESTING AT HIGH ALTITUDE, A DIFFERENTIAL PRESSURE CAN FORM BETWEEN THE INSIDE OF THE CARTRIDGE AND THE OUTSIDE LOW ATMOSPHERIC PRESSURE ENVIRONMENT. THIS DIFFERENTIAL PRESSURE CAN INHIBIT OR REDUCE THE WASH BUFFER FLOW BY CAUSING BUFFER TO BLOCK ONE OF THE AIR-VENT HOLES. CORRECTIVE ACTIONS ARE DOCUMENTED IN THE FDA SUMMARY REPORT SUBMITTED WITH THE RECALL NOTIFICATION. A PERMANENT SOLUTION IS BEING INVESTIGATED WITH THE UTMOST URGENCY.

    Description of Event or Problem · 1

    THE EVENT WAS REPORT IN (B)(6) AND RELATED TO THE USE OF THE IN2IT (I) SYSTEM A1C TEST CARTRIDGES AT HIGH ALTITUDE. BASED ON THE A1C RESULTS, PT TREATMENT WAS CHANGED. THE PT WENT TO HOSPITAL BECAUSE OF HYPOGLYCEMIA THE FOLLOWING DAY, WAS TREATED AND CONTROLLED. IMPACT TO THE PT WAS SHORT-TERM WITH NO LASTING EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN2IT (I) A1C TEST CARTRIDGES GLYCOSYLATED HEMOGLOBIN ASSAY LCP BIO-RAD LABORATORIES DEESIDE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization