MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-05 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter Inc..
[2113515]
A customer contacted beckman coulter inc. (bec) to report obtaining a (b)(6) cytomegalovirus immunoglobulin g (cmv-igg) result for one (1) patient, generated by the unicel dxi 800 access immunoassay system. The result was reported out of the lab. Subsequent testing of the patient's sample on an alternate methodology generated a "(b)(6)" result. The patient's second sample was analyzed on an alternate dxi instrument on (b)(6) 2011 and results were also (b)(6). The customer did not receive any report of patient injury requiring medical intervention or change to patient treatment attributed or connected to this event.
Patient Sequence No: 1, Text Type: D, B5
[9287398]
Sample collection and centrifugation information have not been supplied to date. Per the customer supplied qc data, cmv-igg qc was within the customer's established range the day of the event and after the event. Additional system information has not been supplied to date. Customer product line support (cpls) testing of patient's samples tended to (b)(6) presence of cmv igg. A clear root cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-02137 |
| MDR Report Key | 2150043 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-05 |
| Date of Report | 2011-06-07 |
| Date of Event | 2011-05-13 |
| Date Mfgr Received | 2011-06-07 |
| Device Manufacturer Date | 2008-05-16 |
| Date Added to Maude | 2012-05-01 |
| 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 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE |
| Product Code | OMI |
| Date Received | 2011-07-05 |
| Model Number | DXI 800 |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID Number | SW VERSION 4.3 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-07-05 |