BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1447123 · Received August 24, 2009

    Report

    Report Number
    2919069-2009-00301
    Event Type
    Malfunction
    Date Received
    August 24, 2009
    Date of Event
    July 21, 2009
    Report Date
    August 12, 2009
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION (B)(4) OTHER: INTERFERING SUBSTANCE, SAMPLE RELATED. INVESTIGATION SUMMARY: DATA SUBMITTED WAS REVIEWED. THE SUBMITTED DATA SUGGESTED THAT THE RESULTS OF SOME OF THE ABNORMAL SAMPLES WERE CORRECTLY FLAGGED; HOWEVER, THERE WERE ALSO SOME DATA, WHICH SHOWED THAT THE INSTRUMENT HAD FAILED TO CORRECTLY MEASURE THE MPV PARAMETER. ALL THE SAMPLE DATA SUBMITTED WERE FROM ABNORMAL PATIENTS WITH INTERFERING CONDITIONS OR SUBSTANCES, LIKE GIANT PLT, PLT CLUMPS, RBC, AND WBC FRAGMENTS OR SOME OTHER UNKNOWN CONDITIONS, WHICH COULD HAVE AFFECTED THE SAMPLE PROCESSING AND THE CORRECTNESS OF THE RESULTS GENERATED BY THE CELL-DYN SAPPHIRE. THESE INTERFERING SUBSTANCES AND CONDITIONS ARE STATED IN THE PRODUCT LABELING. A REVIEW OF THE FILES CONCLUDED THAT THE HIGH MPV VALUES FOR THE SAMPLES WITH LOW PLTI COUNTS WERE CAUSED BY NOISE IN THE PLTI HISTOGRAM AND THAT THE NOISE SEEN WAS CAUSED BY RBC OR WBC FRAGMENTS, WHICH HAVE BEEN IDENTIFIED AS POSSIBLE INTERFERING SUBSTANCE. NOTE: 1. THERE IS A CASE WHERE THE PLTI NUMERICAL RESULT IS SUPPRESSED AND THUS, LOOKS LIKE IT HAS THE NO CALCULATION STATUS, WHEN IN FACT IT DOES NOT. THIS HAPPENS IF THE PLTI NUMERICAL RESULT IS <20 K/UL AND THERE IS NO PIC/POC DELTA DATA FAULT. THE PLTI ACTUALLY HAS AN OK STATUS IN THIS CASE. THIS SPECIFICATION IS ALSO STATED IN THE PRODUCT LABELING. THE TWO SAMPLES SUBMITTED (B)(4) WITH BLANK PLTI RESULTS AND FALSELY HIGH MPV HAD AN NVWBC FLAG THAT ADDRESSES THE POSSIBLE PRESENCE OF WBC FRAGMENTS, WHICH IS AN INTERFERING SUBSTANCE FOR MPV. ALTHOUGH, THE PLTI WAS NOT DISPLAYED BECAUSE IT IS LESS THAN 20K/L, INTERNALLY, THE PLTI WAS MEASURED AND MUST HAVE CORRELATED TO THE PLTO RESULT; THEREFORE; A PIC/POC DELTA FLAG WOULD NOT BE TRIGGERED. A REVIEW OF COMPLAINTS DID NOT FIND AN ADVERSE TREND FOR THE COMPLAINT ISSUE. BASED ON THE INFORMATION ABOVE, IT WAS DETERMINED THAT THERE IS NO PRODUCT DEFICIENCY FOR THE COMPLAINT ISSUE ON THE CELL-DYN SAPPHIRE. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A FALSELY LOW PLTO (OPTICAL PLATELET) RESULT WAS GENERATED FOR ONE PATIENT SAMPLE PROCESSED USING A CELL-DYN SAPPHIRE ANALYZER. THE FOLLOWING INITIAL RESULTS WERE OBTAINED: PLTO=14.6 K/UL, PLTI=31.3 K/UL AND MPV=16.0 FL WITH INVALID FLAG. THE SAMPLE WAS REPEATED YIELDING THE FOLLOWING RESULTS; PLTO=24.2 K/UL, PLTI=26.5 K/UL AND MPV=17.6 FL. NO ADVERSE OUTCOMES RELATED TO THIS ISSUE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) DIL/SHT REAGENT LN 1H73-01 LOT# UKNOWN| (B)(4) DIL/SHT REAGENT LN 1H73-01 LOT# UKNOWN