ANALYTICAL D MODULE

Description of Event or Problem

THE CUSTOMER HAD BEEN HAVING ISSUES WITH ASPARTATE AMINOTRANSFERASE ACC. TO (B)(6) WITH/WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST) ON THEIR D- MODULE SINCE (B)(6) 2012. THE CUSTOMER HAD TO ISSUE 43 CORRECTED REPORTS. THE CUSTOMER PROVIDED DATA FOR 29 PATIENTS, OF WHICH 27 PATIENTS HAD DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. REPEAT TESTING WAS PERFORMED ON THE ORIGINAL ANALYZER. THE SAMPLES WERE PROCESSED IN THE MODULAR PRE ANALYTICS DEVICE AND THE ORIGINAL TUBES WERE SENT TO THE D- MODULE ANALYZER. THE FIRST PATIENT'S INITIAL AST RESULT WAS 11 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 22 U/L. THE SECOND PATIENT, A MALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 11 U/L FROM A SERUM SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 24 U/L. THE THIRD PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 12 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 29 U/L. THE FOURTH PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 13 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 29 U/L. THE FIFTH PATIENT, A MALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 13 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 26 U/L. THE SIXTH PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 6 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 22 U/L. THE SEVENTH PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 10 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 27 U/L. THE EIGHTH PATIENT, A MALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 8 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 24 U/L. THE NINTH PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 6 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 25 U/L. ON (B)(6) 2012, THE TENTH PATIENT, A MALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 10 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 26 U/L. ON (B)(6) 2012, THE ELEVENTH PATIENT, A MALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 10 U/L. ON (B)(6) 2012, THE REPEAT RESULT WAS 32 U/L. IT IS UNCLEAR IF IT WAS A PLASMA OR SERUM SAMPLE. ON (B)(6) 2012, THE TWELFTH PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 13 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 31 U/L. ON (B)(6) 2012, THE THIRTEENTH PATIENT, A MALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 9 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 22 U/L. ON (B)(6) 2012, THE FOURTEENTH PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 6 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 34 U/L. ON (B)(6) 2012, THE FIFTEENTH PATIENT, A MALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 7 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 29 U/L. ON (B)(6) 2012, THE SIXTEENTH PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 8 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 35 U/L. ON (B)(6) 2012, THE SEVENTEENTH PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 6 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 24 U/L. ON (B)(6) 2012, THE EIGHTEENTH PATIENT, A FEMALE BORN (B)(6), HAD AN INITIAL AST RESULT OF 13 U/L FROM A PLASMA SAMPLE. ON (B)(6) 2012, THE REPEAT RESULT WAS 22 U/L. THE NINETEENTH PATIENT HAD AN INITIAL AST RESULT OF 14 U/L FROM A PLASMA SAMPLE. THE REPEAT RESULT WAS 29 U/L. THE DATES OF THE INITIAL AND REPEAT RESULTS ARE UNKNOWN. THE TWENTIETH PATIENT HAD AN INITIAL AST RESULT OF 11 U/L FROM A PLASMA SAMPLE. THE REPEAT RESULT WAS 30 U/L. THE DATES OF THE INITIAL AND REPEAT RESULTS ARE UNKNOWN. THE TWENTY FIRST PATIENT HAD AN INITIAL AST RESULT OF 7 U/L FROM A PLASMA SAMPLE. THE REPEAT RESULT WAS 24 U/L. THE DATES OF THE INITIAL AND REPEAT RESULTS ARE UNKNOWN. THE TWENTY SECOND PATIENT HAD AN INITIAL AST RESULT OF 12 U/L FROM A PLASMA SAMPLE. THE REPEAT RESULT WAS 29 U/L. THE DATES OF THE INITIAL AND REPEAT RESULTS ARE UNKNOWN. THE TWENTY THIRD PATIENT HAD AN INITIAL AST RESULT OF 9 U/L FROM A PLASMA SAMPLE. THE REPEAT RESULT WAS 28 U/L. THE DATES OF THE INITIAL AND REPEAT RESULTS ARE UNKNOWN. THE TWENTY FOURTH PATIENT HAD AN INITIAL AST RESULT OF 10 U/L FROM A SERUM SAMPLE. THE REPEAT RESULT WAS 38 U/L. THE DATES OF THE INITIAL AND REPEAT RESULTS ARE UNKNOWN. THE TWENTY FIFTH PATIENT HAD AN INITIAL AST RESULT OF 8 U/L FROM A PLASMA SAMPLE. THE REPEAT RESULT WAS 24 U/L. THE DATES OF THE INITIAL AND REPEAT RESULTS ARE UNKNOWN. THE TWENTY SIXTH PATIENT HAD AN INITIAL AST RESULT OF 14 U/L FROM A PLASMA SAMPLE. THE REPEAT RESULT WAS 28 U/L. THE DATES OF THE INITIAL AND REPEAT RESULTS ARE UNKNOWN. THE TWENTY SEVENTH PATIENT HAD AN INITIAL AST RESULT OF 14 U/L FROM A PLASMA SAMPLE. THE REPEAT RESULT WAS 35 U/L. THE DATES OF THE INITIAL AND REPEAT RESULTS ARE UNKNOWN. THE CUSTOMER CONSIDERED THE REPEAT RESULTS TO BE CORRECT. NO PATIENTS WERE TREATED OR ADVERSELY AFFECTED BY THE ERRONEOUS RESULTS. THE AST R1 REAGENT LOT NUMBER WAS (B)(4) AND THE EXPIRATION DATE WAS 07/31/2012. THE AST R2 REAGENT LOT NUMBER WAS (B)(4) AND THE EXPIRATION DATE WAS 03/31/2012. THE FIELD SERVICE REPRESENTATIVE FOUND A FLUIDICS FAILURE; THE REAGENT DISPENSE WAS ERRATIC. HE CLEANED BOTH MULTISWITCH VALVES AND BLEACHED CHANNELS 4 AND 7 AND SAMPLE PROBE. HE REPLACED THE REAGENT DISPENSE NOZZLE TIPS AND PERFORMED A RINSE AND PRIME ON ALL. HE REPLACED THE LAMP AND CELLS. HE RAN A PRECISION TEST AND VERIFIED ALL RESULTS WERE WITHIN GUIDELINES. THE CUSTOMER CALIBRATED AND RAN QUALITY CONTROL AND VERIFIED THE RESULTS WERE WITHIN THE CUSTOMER'S RANGE.

Additional Manufacturer Narrative

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.