BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2221180 · Received August 17, 2011

    Report

    Report Number
    2027969-2011-01848
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER COMPLAINT, CUSTOMER DID NOT APPLY SUFFICIENT BLOOD DURING ONE TEST AND SMEARED SAMPLE DURING OTHER TEST. CUSTOMER MILKS FINGER WHEN HE DOES NOT GET ENOUGH SAMPLE FOR TESTING. PER PRODUCT USER GUIDE - PRECAUTIONS AND WARNINGS, "DO NOT USE REPETITIVE PRESSURE TO COLLECT THE SAMPLE." SQUEEZING THE FINGERSTICK SITE EXCESSIVELY (MILKING) RELEASES INTERSTITIAL FLUID AND MAY CAUSE INACCURATE RESULTS. NES ERROR OCCURS WHEN THERE IS NOT ENOUGH SAMPLE APPLIED TO THE TEST STRIPS TO FILL THE TEST AREA, AND/OR STRIP CHANNEL IS BLOCKED. (B)(4). THIS REACHES THE ACTION THRESHOLD OF (B)(4). NOTE BRICK LOT NUMBER 246544 HAS STRIP CODE Z45BU MATERIAL WAS SPLIT INTO TWO DIFFERENT LOTS: LOT # 243104 INTO 12 PACKS (SMALLER LOT), LOT # 251117 INTO 48 PACKS (LARGER LOT). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF (B)(4), CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. IN HOUSE TEST WAS PERFORMED ON LOT NUMBER 243104 FOR ANOTHER COMPLAINT; NO ERROR WAS FOUND. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    PT REPORT LO ERRORS WHEN TESTING. PT HAD ERROR LAST WEEK ON FIRST TRY AND REPEAT GAVE RESULT IN PT'S NORMAL RANGE. TECH SVC HELPED CUSTOMER LOOK UP ERROR IN METER MEMORY; IT WAS NES. TECH SVC HAD PT CHECK STRIPS FROM TODAY AND BOTH HAD AT LEAST ONE CHANNEL THAT WAS NOT FILLED COMPLETELY. ONE DID NOT HAVE BLOOD LEFT IN THE SAMPLE WELL, AND THE OTHER HAD BLOOD SMEARED AROUND THE EDGES OF THE SAMPLE WELL. PT TYPICALLY DOES NOT SQUEEZE HIS FINGER TO GET BLOOD. IF HE DOES NOT HAVE ENOUGH, HOWEVER, HE THEN MILKS HIS FINGER. PT MENTIONED THAT HIS FINGERS ARE BRUISED AROUND THE FINGERSTICK SITE WHICH IS UNUSUAL FOR HIM. YESTERDAY ((B)(6) 2011), HE SCRAPED HIS FINGER BY ACCIDENT AND NOTICED THAT IT BLED FOR A LONG TIME. TECH SVC ADVISED DISCUSSING WITH HIS DOCTOR AND GETTING A LAB TEST DONE IF RETEST ON HIS METER DOES NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other