UNICEL DXC 800 ACCESS IMMUNOASSAY SYSTEM
Report
- Report Number
- 2122870-2011-03511
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- March 30, 2011
- Report Date
- March 30, 2010
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- PMA / PMN Number
- K023764
- Removal / Correction Number
- Z-1318-2010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
SAMPLES WERE COLLECTED IN PLASTIC LITHIUM HEPARIN PLASMA TUBES WITH A GEL SEPARATOR. SAMPLES WERE CENTRIFUGED SAMPLES FOR THREE MINS IN A STATSPIN CENTRIFUGE; EXACT SPEED WAS NOT PROVIDED. ACCUTNI QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT AT APPROX 01:00 ON (B)(4) 2010. THE CUSTOMER RERAN ACCUTNI QC AFTER THE EVENT AT APPROX 20:00 AND IT FAILED. SPECIFIC QC DATA WAS NOT PROVIDED. THE CUSTOMER ATTEMPTED TO RECALIBRATE THE ACCUTNI ASSAY AND THE CALIBRATION FAILED AS WELL. CALIBRATION DATA WAS NOT PROVIDED. THE CUSTOMER PERFORMED A ROUTINE SYSTEM CHECK ON (B)(4) 2010, WHICH FAILED WITH A HIGH SUBSTRATE MEAN AND WASH %CV (COEFFICIENT OF VARIATION). ON (B)(4) 2010, A BECKMAN COULTER, INC EMPLOYEE SPOKE TO THE CUSTOMER REGARDING THE INVESTIGATION AND EVENT. THE CUSTOMER NOTES THAT THEY ARE RUNNING ALL TROPONINS IN DUPLICATE AND ALSO RUNNING THEM ON ANOTHER INSTRUMENT. THE ASSAY IS STILL NOT PERFORMING WELL. THE BCI EMPLOYEE REITERATED TO CUSTOMER THAT THE ASSAY SHOULD NOT BE RUN ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM PER (B)(4). THE CUSTOMER UNDERSTOOD AND WILL CONTINUE TO MONITOR THE ASSAY. NO ADD'L ASSISTANCE WAS REQUESTED AT THIS TIME. ON (B)(4) 2010, THE FIELD SERVICE ENGINEER DETERMINED THAT THE INSTRUMENT WAS GENERATING ELEVATED SUBSTRATE RLU (RELATIVE LIGHT UNITS) AT 9500 (INSTRUMENT SPECIFICATION IS <9000). PERFORMED A SUBSTRATE DECONTAMINATION PROCEDURE AND VERIFIED THE RESULTS; SUBSTRATE RLUS WERE THEN WITHIN INSTRUMENT SPECIFICATIONS. REPLACED THE PERI-PUMP AND LUBRICATED ALL RAILS. PERFORMED A ROUTINE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. RECALIBRATED ALL ASSAYS AND PERFORMED QC; NO ISSUES WERE NOTED. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 8 OF 50 REPORTED BY THIS CUSTOMER. THE 50 RELATED MDRS THAT HAVE BEEN REPORTED ARE: MDR 2122870-2011-03504, 03505, 03506, 03507, 03508, 03509, 03510, 03512, 03513, 03514, 03515, 03516, 03517, 03518, 03519, 03520, 03521, 03522, 03523, 03524, 03525, 03526, 03527, 03528, 03529, 03530, 03531, 03532, 03533, 03534, 03535, 03536, 03537, 03538, 03539, 03540, 03541, 03542, 03543, 03544, 03545, 03546, 03547, 03548, 03549, 03550, 03551, 03552, 03553.
CUSTOMER REPORTED ERRONEOUS HIGH ACCU TNI (TROPONIN I) TEST RESULTS WERE OBTAINED FOR 50 PT SAMPLES TESTED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THERE WERE MULTIPLE PT TEST RESULTS ABOVE NORMAL RANGE OF 0.04 NG/ML AND BELOW THE AMI (ACUTE MYOCARDIAL INFARCTION) CUTOFF OF 0.50 NG/ML, I.E. 0.05 - 0.49 NG/ML. WHEN THE SAMPLES WERE REPEATED ON THE OTHER UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, RESULTS WERE IN THE NORMAL RANGE (<0.04 NG/ML). THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THE TEST RESULTS WERE QUESTIONED. SAMPLES WERE RETESTED AND CORRECTED REPORTS WERE ISSUED. THE INITIAL ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. WHILE THERE IS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNK WHETHER THERE WAS A CHANGE TO PT MANAGEMENT. THIS IS EVENT 8 OF 50 FOR THE 50 PT SAMPLES INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL DXC 800 ACCESS IMMUNOASSAY SYSTEM | JJE | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ACCESS ACCU TNI |