UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
Report
- Report Number
- 2122870-2011-01892
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- December 9, 2008
- Report Date
- December 9, 2008
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- PMA / PMN Number
- K023764
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE RAN HIGH SENSITIVITY SYSTEM CHECK THAT PASSED SPECS. ALSO, THE FSE PERFORMED A CARRYOVER TEST THAT FAILED SPECS. THE FSE CLEANED THE WASH STATION AND RAN THE CARRYOVER TESTED AGAIN AND IT FAILED SPECS. THE FSE REPLACED THE SAMPLE PIPETTOR AND PERFORMED ALIGNMENTS FOR THE PIPETTOR. THEN REPEATED THE CARRYOVER TESTING AND IT PASSED SPECS. CALIBRATIONS WERE PERFORMED BY THE FSE AND THE QC WAS WITHIN SPECS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS TWO OF TWO REPORTS RELATED TO THREE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT OCCURRING ON TWO DIFFERENT DAYS. SEE REFERENCE MDR NUMBERS: 2122870-2011-01891 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULTS OBTAINED FROM A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR THREE PTS. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THE CUSTOMER INDICATED THAT THEY HAVE REFLEX CONDITIONS SETUP ON THE SYSTEM THAT ANY A TNI RESULTS THAT IS >0.06 WILL AUTOMATICALLY BE REPEATED. THE CUSTOMER ALSO INDICATED THAT FOUR LEVELS OF QUALITY CONTROLS (QC) ARE RUN THREE TIMES A DAY. QC WAS WITHIN SPECS BEFORE AND AFTER THE EVENT. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCES OR CHANGE TO THE PT'S TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.
THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE RAN HIGH SENSITIVITY SYSTEM CHECK THAT PASSED SPECS. ALSO, THE FSE PERFORMED A CARRYOVER TEST THAT FAILED SPECS. THE FSE CLEANED THE WASH STATION AND RAN THE CARRYOVER TESTED AGAIN AND IT FAILED SPECS. THE FSE REPLACED THE SAMPLE PIPETTOR AND PERFORMED ALIGNMENTS FOR THE PIPETTOR. THEN REPEATED THE CARRYOVER TESTING AND IT PASSED SPECS. CALIBRATIONS WERE PERFORMED BY THE FSE AND THE QC WAS WITHIN SPECS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS TWO OF TWO REPORTS RELATED TO THREE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT OCCURRING ON TWO DIFFERENT DAYS. SEE REFERENCE MDR NUMBERS: 2122870-2011-01891 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULTS OBTAINED FROM A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR THREE PTS. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THE CUSTOMER INDICATED THAT THEY HAVE REFLEX CONDITIONS SETUP ON THE SYSTEM THAT ANY A TNI RESULTS THAT IS >0.06 WILL AUTOMATICALLY BE REPEATED. THE CUSTOMER ALSO INDICATED THAT FOUR LEVELS OF QUALITY CONTROLS (QC) ARE RUN THREE TIMES A DAY. QC WAS WITHIN SPECS BEFORE AND AFTER THE EVENT. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCES OR CHANGE TO THE PT'S TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.
THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE RAN HIGH SENSITIVITY SYSTEM CHECK THAT PASSED SPECS. ALSO, THE FSE PERFORMED A CARRYOVER TEST THAT FAILED SPECS. THE FSE CLEANED THE WASH STATION AND RAN THE CARRYOVER TESTED AGAIN AND IT FAILED SPECS. THE FSE REPLACED THE SAMPLE PIPETTOR AND PERFORMED ALIGNMENTS FOR THE PIPETTOR. THEN REPEATED THE CARRYOVER TESTING AND IT PASSED SPECS. CALIBRATIONS WERE PERFORMED BY THE FSE AND THE QC WAS WITHIN SPECS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS TWO OF TWO REPORTS RELATED TO THREE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT OCCURRING ON TWO DIFFERENT DAYS. SEE REFERENCE MDR NUMBERS: 2122870-2011-01891 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULTS OBTAINED FROM A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR THREE PTS. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THE CUSTOMER INDICATED THAT THEY HAVE REFLEX CONDITIONS SETUP ON THE SYSTEM THAT ANY A TNI RESULTS THAT IS >0.06 WILL AUTOMATICALLY BE REPEATED. THE CUSTOMER ALSO INDICATED THAT FOUR LEVELS OF QUALITY CONTROLS (QC) ARE RUN THREE TIMES A DAY. QC WAS WITHIN SPECS BEFORE AND AFTER THE EVENT. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCES OR CHANGE TO THE PT'S TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM | JJE | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | ACCESS ACCUTNI | ||
| 2 | 76 YR | ACCESS ACCUTNI | ||
| 3 | 91 YR | ACCESS ACCUTNI |