MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-22 for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2040173]
The customer reported elevated creatine kinase-mb (ck-mb) results, above the reference range, on multiple pt samples involving unicel dxi 800 access immunoassay system. The number of pt samples affected is unk. The customer received ck-mb results of 80 ng/ml. After the samples were re-spun, results were produced at 4 ng/ml. The elevated results did not correlate with the pts' clinical conditions. One sample was retested on an access 2 system and produced a result of 2 ng/ml. The elevated results were not released out of the laboratory. There has been no report of pt injury or change in pt treatment associated with this event. The field service engineer (fse) went to the facility and assessed the unit.
Patient Sequence No: 1, Text Type: D, B5
[9278136]
The field service engineer (fse) serviced the unit on (b)(4) 2008. The fse discovered the aspirate probes did not evacuate the reaction vessel at the same rate. The fse performed and completed system check but noted to be near the high end of specifications. The fse replaced the aspirate probes and tubing. The fse replaced and realigned the wash pick 'n place. The fse retested and passed system check but noted to be near the high end of specifications. The fse advised the customer to retest the samples on access 2 system if erroneous ck-mb results occur, prior to re-spinning. Quality control (qc) was performed and conformed to specifications. The customer performed system check which confirmed to specifications. Wash pick 'n place. Sample collection and centrifugation data was not supplied. Pt results data was not supplied. Quality control (qc) data was not supplied by the customer. This reportable event was identified during a retrospective review of product complaints conducted from (b)(4) 2008 through (b)(4) 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-02363 |
| MDR Report Key | 2185126 |
| Report Source | 05,06 |
| Date Received | 2011-07-22 |
| Date of Report | 2008-04-03 |
| Date of Event | 2008-04-03 |
| Date Mfgr Received | 2008-04-03 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2011-09-20 |
| 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 DR |
| 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 DXI 800 ACCESS IMMUNOASSAY SYSTEM |
| Product Code | JHS |
| Date Received | 2011-07-22 |
| 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 DR CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-22 |