MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-23 for UNICEL? DXL800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2001876]
The customer reported that on (b)(6) 2011 and (b)(6) 2011 multiple, imprecise unconjugated estriol (ue3) results were generated from a unicel dxl800 access immunoassay system. The exact number of involved results in unknown. This report represents the event date of (b)(6) 2011. The initial, questionable results were reported out of the laboratory. There has been no information provided which indicates the results led to a death, serious injury or modification to patient treatment. Repeat results were generated by the laboratory. A comparison of repeat results in relation to initial results values was performed by the customer's genetic laboratory. It was determined that the amount of discrepancy was not significant enough, in all cases but one, to change clinical interpretation of the results. One amended report was reported. The customer was not able to provide initial or repeat result data associated with the amended report. Data supplied by the customer was assessed. The assessment indicated that there were no repeat tests with a difference of 10% or greater when compared to initial results. However there were several repeat results that were impossible to correlate to initial results because of customer manually programmed sample identification issues. Data supplied by the customer also indicated that quality control results (qc) were outside the customer's established ranges for levels 1 & 3 prior to event. Ue3 calibration on (b)(6) 2011 met specification. The customer noted no issues with other assays. The customer indicated that the total allowable error (tea) employed for ue3 precision assessments during this event was 15%. Beckman coulter inc. Claims an achievable tea for ue3 of 30%.
Patient Sequence No: 1, Text Type: D, B5
[9049882]
The field service engineer (fse) performed a system check. The unwashed and substrate portions of the assessment failed to meet specification. The fse replaced a number of parts without success. Ultimately he replaced the substrate pump. Subsequent verification testing, including an executed system check, met established specification. Although repairs were made through on-site service, a definitive root cause for this event has not been identified to date. The following are mdrs associated with this event: 2122870-2011-01532, 2122870-2011-01543. This is report one of two.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01543 |
| MDR Report Key | 2099896 |
| Report Source | 05,06 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-04-30 |
| Date of Event | 2011-04-28 |
| Date Mfgr Received | 2011-04-30 |
| Device Manufacturer Date | 2004-08-26 |
| Date Added to Maude | 2012-04-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXL800 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY |
| Product Code | CGI |
| Date Received | 2011-05-23 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-23 |