MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-06 for UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM N/A 973100 manufactured by Beckman Coulter Inc..
[17059638]
A customer contacted beckman coulter inc. (bci) in regards ckmb result above the normal reference range for one patient sample generated by unicel dxi 800 access immunoassay analyzer. Patient sample was re-centrifuged and repeated on the same unit and alternate unit. The results obtained from both runs were within normal ckmb reference range. The erroneous results were not reported out of the laboratory. Patient treatment was not impacted by this event.
Patient Sequence No: 1, Text Type: D, B5
[17285891]
The sample was collected in a pst tube and centrifuged for 10 minutes at 3400 rpm. The tube was not properly filled to the fill line. Two levels of qc are run every 8 hours and have been recovering with the customer's established ranges. A bci field service engineer (fse) performed preventive maintenance and verification testing which met the published specification. No hardware issues were detected that would have contributed to this event. A clear root cause of this event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00395 |
| MDR Report Key | 1787607 |
| Report Source | 05 |
| Date Received | 2010-08-06 |
| Date of Report | 2010-08-06 |
| Date of Event | 2010-07-13 |
| Date Mfgr Received | 2010-07-13 |
| Device Manufacturer Date | 2007-08-30 |
| Date Added to Maude | 2010-08-11 |
| 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 BLVD |
| Manufacturer City | BREA 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETERIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2010-08-06 |
| Model Number | N/A |
| Catalog Number | 973100 |
| Lot Number | N/A |
| 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 | 2010-08-06 |