MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-29 for UNICEL? DXI 800 ACCESS IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter Inc..
[1920209]
A customer contacted beckman coulter inc. , (bci) in regards to obtaining falsely elevated creatinine kinase - mb (ckmb) results for multiple samples on one patient that were generated by the unicel dxi 800 access immunoassay system. The erroneous results were reported out of the laboratory. There has been no report of patient injury, death, or change to treatment received to bci to date.
Patient Sequence No: 1, Text Type: D, B5
[9087716]
The samples were plasma collected into a bd plastic lithium heparin gel tube. Samples were centrifuged via the automation line and were tested using the primary tubes. Qc was in range on each day samples were tested. System checks not provided. The issue remains isolated to this one patient. A field service engineer (fse) was dispatched on (b)(6) 2008 for this event. The fse performed troubleshooting and performed all necessary alignments. The fse verified repairs per established procedures and results met published performance specifications. The customer sent the patient's samples to customer product line support (cpls) for further testing. Cpls testing confirmed the presence a heterophile interferent, which is observed as the root cause of this event. This reportable event was identified during a retrospective review of complaints within the date range of (b)(6) 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-00862 |
| MDR Report Key | 2032563 |
| Report Source | 06 |
| Date Received | 2011-03-29 |
| Date of Report | 2008-04-03 |
| Date of Event | 2008-04-03 |
| Date Mfgr Received | 2008-04-03 |
| Device Manufacturer Date | 2006-06-15 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXI 800 ACCESS IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2011-03-29 |
| Model Number | DXI 800 |
| Catalog Number | 973100 |
| Lot Number | N/A |
| 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 | 2011-03-29 |