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 2011-04-13 for UNICEL? DXI 600 ACCESS? IMMUNOASSAY ANALYZER A71461 manufactured by Beckman Coulter, Inc..
[9113538]
This follow-up report is submitted to correct the instrument part number. The correct part number is a71461.
Patient Sequence No: 1, Text Type: N, H10
[20826225]
The samples were collected in bd lithium heparin plasma 13 x 75 gel separator tubes. Centrifugation information has not been supplied to date. The first patient sample (1/1) was full of debris. Qc is performing per the customer's expectations. Specific qc data has not been supplied to date. System check data has not been supplied to date. Service was not dispatched for this event. No definitive root cause could be determined for this event.
Patient Sequence No: 1, Text Type: N, H10
[20838132]
A customer contacted beckman coulter, inc. (bci) in regards to an erroneously elevated ckmb result, above the normal reference range, generated by unicel dxi 600 access immunoassay system for one patient. The result was reported out of the lab. Repeat testing produced results within the normal reference range. The patient's orthopaedic knee surgery was postponed and the patient was admitted to the cardiac catheterization unit after the elevated result was obtained. There was no death or injury to the patient as a result of the erroneous result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2011-00977 |
| MDR Report Key | 2055111 |
| Report Source | 01,05,06 |
| Date Received | 2011-04-13 |
| Date of Report | 2011-03-16 |
| Date of Event | 2011-03-10 |
| Date Mfgr Received | 2011-03-16 |
| Device Manufacturer Date | 2009-11-12 |
| Date Added to Maude | 2011-04-14 |
| 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 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 600 ACCESS? IMMUNOASSAY ANALYZER |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2011-04-13 |
| Model Number | DXI 600 |
| Catalog Number | A71461 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Hospitalization; 2. Other | 2011-04-13 |