The customer reported obtaining multiple erroneous thyroglobulin antibody (access thyroglobulin antibody ii) and thyroglobulin (access thyroglobulin) results for one (1) patient on the laboratory's access 2 immunoassay system (serial number (b)(4)).The customer reanalyzed the patient's samples on the laboratory's alternate access 2 immunoassay system (serial number (b)(4)) and obtained lower results, both within the same clinical category and in different clinical categories.Initial results were reported out of the laboratory and were questioned by the physician.The samples were reanalyzed and corrected reports were sent out.The customer was unaware of change to patient treatment associated with this event.Mdr 2122870-2015-00378 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for three (3) patients.Mdr 2122870-2015-00391 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for two (2) patients.Mdr 2122870-2015-00392 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for four (4) patients.Mdr 2122870-2015-00393 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for two (2) patients.Mdr 2122870-2015-00394 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for one (1) patient.Mdr 2122870-2015-00395 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for five (5) patients.Mdr 2122870-2015-00396 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for two (2) patients.Mdr 2122870-2015-00397 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for five (5) patients.Mdr 2122870-2015-00398 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for four (4) patients.Mdr 2122870-2015-00399 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for three (3) patients.Mdr 2122870-2015-00401 will address the access thyroglobulin antibody ii results obtained on (b)(6) 2015 for one (1) patient.Mdr 2122870-2015-00402 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for one (1) patient.Mdr 2122870-2015-00403 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for eight (8) patients.Qc (quality controls), calibrations and system checks were all performing within assay and instrument specifications prior to (b)(6) 2015.On (b)(6) 2015 system check failed to meet specifications and a precision test for the access thyroglobulin antibody ii failed as all results were zero (0).The patient samples were drawn in serum tubes with and without gel separators.The samples are either drawn in-house or sent from another facility.The in-house samples are centrifuged at 3,500 revolutions per minute (rpm) at room temperature for five (5) minutes.No issue with sample integrity was reported by the customer.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer.
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A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer.The fse discovered foaming in the wash pump during the dispense probes prime cycle.The fse determined the foaming was due to a faulty wash valve rotor.The fse observed wear on the rotor shaft key which was causing foaming at the supply position.The rotor was replaced.After the repairs were completed, the fse performed hardware and system verification tests which passed within published performance specifications.In conclusion, the wash valve rotor was determined to be the cause of this event.All associated mdrs for this event: mdr 2122870-2015-00378, mdr 2122870-2015-00391, mdr 2122870-2015-00392, mdr 2122870-2015-00393, mdr 2122870-2015-00394, mdr 2122870-2015-00395, mdr 2122870-2015-00396, mdr 2122870-2015-00397, mdr 2122870-2015-00398, mdr 2122870-2015-00399, mdr 2122870-2015-00400, mdr 2122870-2015-00401, mdr 2122870-2015-00402, mdr 2122870-2015-00403.(b)(4).
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