MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-10 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter Inc..
[1516390]
A customer obtained lower than expected results for progesterone on one patient's sample. The result was reported out of the lab and questioned by the physician. Upon repeat higher results were obtained within a different clinical range. The customer stated it was possible that the patient received progesterone therapy as a result of this erroneous result. The customer did not have additional information.
Patient Sequence No: 1, Text Type: D, B5
[8339440]
The specimen was collected at a (b)(4) clinic in a sst tube and centrifuged at 3,000 rpm for 5 minutes. The sample was then transported to (b)(4) labs and tested on the dxi 800 analyzer. The specimen was not aliquoted or re-centrifuged prior to analysis. Qc was within the customer's established ranges prior to the event. Customer did not question any other results or assays. A field service engineer (fse) was dispatched: the fse performed hardware verification. All verification testing met specifications. No hardware issues were noted. Per fse, the sample in question had a normal appearance; no visible fibrin, hemolysis or lipemia were noted. A definitive root cause for this event has not been determined to date. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2009-00378 |
| MDR Report Key | 1556937 |
| Report Source | 05 |
| Date Received | 2009-12-10 |
| Date of Report | 2009-12-10 |
| Date of Event | 2009-11-25 |
| Date Mfgr Received | 2009-11-25 |
| Device Manufacturer Date | 2006-03-21 |
| Date Added to Maude | 2009-12-14 |
| 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 | 3 |
| 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 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| 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 PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | MXZ |
| Date Received | 2009-12-10 |
| Model Number | NA |
| Catalog Number | 973100 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2009-12-10 |