BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUC/LAC CASSETTE

    MDR report key: 1789151 · Received August 9, 2010

    Report

    Report Number
    1823260-2010-04693
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    June 28, 2010
    Report Date
    December 2, 2010
    Product Code
    KHP
    PMA / PMN Number
    K032311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. INVESTIGATION OF THE QUALITY CONTROL DATABASE AND LOGFILES SHOWED THE QUALITY CONTROL RESULTS HAD BEEN WITHIN THE SPECIFIED QUALITY CONTROL RANGES, HOWEVER QUALITY CONTROLS WERE NOT PERFORMED ON THE DAY OF THE EVENT. BASED UPON INFORMATION PROVIDED, THE CUSTOMER IS NOT RUNNING QUALITY CONTROLS AS RECOMMENDED. THE INVESTIGATION OF PROVIDED DATA ALSO SHOWED THE GLUCOSE RESULT FROM PATIENT 3 WAS GENERATED USING THE MSS SENSOR LOT 21501130 (OMNI S6 ANALYZER, SERIAL NUMBER (B)(4)). PATIENT 1 AND PATIENT 2 GLUCOSE RESULTS WERE PERFORMED USING MSS SENSOR LOT 2150212 (OMNI S6 ANALYZER, SERIAL NUMBER (B)(4)). NO INTERFERING COMPOUNDS WERE DETECTED IN THE SAMPLE, HOWEVER, THE HEMATOCRIT VALUE MEASURED IN THE MSS MEASURING CHAMBER WAS VERY LOW WHICH INDICATED A POSSIBLE ISSUE WITH THE SAMPLE DILUTION. BASED UPON INFORMATION PROVIDED, THE EVENT IS MOST LIKELY A SAMPLE RELATED ISSUE. THE ERRONEOUS RESULTS WERE NOT USED FOR THERAPY OR OTHER ACTION ON PATIENTS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE GLUCOSE AND LACTATE RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS. TESTING WAS PERFORMED ON TWO OMNI S6 ANALYZERS. THE OMNI S6 ANALYZER, SERIAL NUMBER (B)(4) HAD MSS SENSOR LOT NUMBER 21501212. THE CUSTOMER PROVIDED RESULTS FOR THREE PATIENT SAMPLES: PATIENT 1, INITIAL GLUCOSE RESULT WAS 72 MG/DL AND INITIAL LACTATE RESULT WAS 5 MG/DL, TESTED ON AN OMNI S6 ANALYZER (SERIAL NUMBER (B)(4)). THE REPEAT GLUCOSE RESULT WAS 105 MG/DL AND REPEAT LACTATE RESULT WAS 10 MG/DL, TESTED ON AN OMNI S6 ANALYZER (SERIAL NUMBER (B)(4)). PATIENT 2, INITIAL GLUCOSE RESULT WAS 59 MG/DL AND INITIAL LACTATE RESULT WAS 5 MG/DL, TESTED ON AN OMNI S6 ANALYZER (SERIAL NUMBER (B)(4)). THE REPEAT GLUCOSE RESULT WAS 95 MG/DL AND REPEAT LACTATE RESULT WAS 7 MG/DL, TESTED ON AN OMNI S6 ANALYZER (SERIAL NUMBER (B)(4)). PATIENT 3, INITIAL GLUCOSE RESULT WAS 36 MG/DL AND INITIAL LACTATE RESULT WAS 4 MG/DL, TESTED ON AN OMNI S6 ANALYZER (SERIAL NUMBER (B)(4)). THE REPEAT GLUCOSE RESULT WAS 106 MG/DL AND REPEAT LACTATE RESULT WAS 10 MG/DL, TESTED ON AN OMNI S6 ANALYZER (SERIAL NUMBER (B)(4)). THE ERRONEOUS RESULTS WERE NOT USED FOR THERAPY BECAUSE THE RESULTS DID NOT FIT THE CLINICAL PICTURE OF THE PATIENTS. NONE OF THE PATIENTS WERE HARMED DUE TO THE ERRONEOUS RESULTS. THE OMNI S6 ANALYZER, SERIAL NUMBER (B)(4), MSS SENSOR LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AT THE END OF AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP OF THE VASOVIEW 7 XB "BROKE INTO MULTIPLE PIECES INSIDE THE PATIENT'S LEG. THE TUNNEL WAS INSPECTED, THEN IRRIGATED AND SUCTIONED. SEVERAL PIECES OF THE TIP WERE EVACUATED." THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. THERE WERE NO OTHER PATIENT EFFECTS REPORTED. THE CORRECT LOT NUMBER COULD NOT BE OBTAINED. ON OCTOBER 28, 2010, RECEIVED USER FACILITY MEDWATCH REPORT #: 3100120000-2010-8036 WITH LOT NUMBER 25012330. THE REPORTED LOT NUMBER COULD NOT BE VERIFIED FOR THE REPORTED PART NUMBER. THE PRODUCT WAS RETAINED BY THE HOSPITAL AND MAY BE AVAILABLE FOR EVALUATION AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUC/LAC CASSETTE GLUCOSE OXIDASE, GLUCOSE KHP 21501212

    Patients

    Seq Age Sex Outcome Treatment
    1