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Patient 1
UPON INVESTIGATION THE LIKELY CAUSE OF THE ISSUE IS ATTRIBUTED TO AN LIS PROGRAMMING, A NON-BIO-RAD PRODUCT. THERE WAS NO EVIDENCE OF MALFUNCTION ON THE D-100 SYSTEM AND THE SYSTEM WAS PERFORMING PER THE MANUFACTURER'S SPECIFICATION AT THE TIME OF INCIDENT. THE CUSTOMER DISCOVERED THAT THE A1C RESULT RECORDED IN THE D-100? SYSTEM DATABASE, FOR THIS SAMPLE, WAS 5.5 % (CORRECT), NOT 11.2%. THE CUSTOMER ALSO EVALUATED THE ASTM FILES AND FOUND THAT THE RESULT SENT TO THE LIS WAS ALSO 5.5%, NOT 11.2%. IFCC AND EAG VALUES WERE ALSO SENT, BUT ONLY THE NGSP CHANGED ERRONEOUSLY AT THE LIS SYSTEM. THE CUSTOMER USES ONE LIS PROGRAM FOR THREE DIFFERENT SYSTEMS (TWO VARIANT? II TURBO SYSTEMS (PLUS ONE PC) AND ONE D-100? SYSTEM). ALTHOUGH THE LIS VENDOR WAS NOT ABLE TO LOCATE THE RAW DATA FOR THIS ONE SAMPLE, IT WAS NOTED THAT THE CUSTOMER HAD CORRECTED AN UNKNOWN SAMPLE ID (I.E. AN UNREAD BARCODE) SENT BY THE VARIANT? II TURBO SYSTEM AT THE LIS. A SAMPLE RESULT WITH AN UNKNOWN SAMPLE ID (I.E. UNREAD BARCODE) CAN OVERWRITE A CORRECTLY-READ BARCODE SAMPLE ID IF IT HAD BEEN TRANSFERRED TO LIS AT THE SAME TIME. THE CUSTOMER WAS SUGGEST TO MAKE EDITS OF UNREAD BARCODES ON THE BIO-RAD SYSTEM AND NOT AT THE LIS TO AVOID OVERWRITING. THE CUSTOMER WAS ALSO SUGGESTED TO SEPARATE THE LIS PC FROM THE D-100? SYSTEM AND VARIANT? II TURBO PC. ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER DUE PATIENT CONFIDENTIALITY. NO FURTHER INCIDENT INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. BIO-RAD CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE. (MAY 4, 2017)