MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-28 for UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM 973100 manufactured by Beckman Coulter, Inc..
[2990085]
The customer reported elevated creatine kinase-mb (ck-mb) results, above the normal reference interval, for two patients, involving unicel dxi 800 access immunoassay system. This report refers to patient #2. The patient sample produced an elevated result of 23. 2 ng/ml. Subsequent analysis of the sample, on an alternate unicel dxi 800 system, recovered a result of 2. 9 ng/ml which was reported to the hospital. The erroneously elevated result was not released from the laboratory. There was no patient consequence associated with this event. Beckman coulter field service engineer (fse) went to the facility and assessed the instrument.
Patient Sequence No: 1, Text Type: D, B5
[10217930]
There is no indication service was dispatched for this reported event. Quality control had been performing within the customer's expectation at the time of the event. Samples were analyzed in 3 ml, green top, plasma separator tubes. Centrifugation was performed at 3,000 rpm (revolutions per minute) for six minutes. The customer stated there were no system errors and both patient samples were normal in appearance with no signs of clots. This medwatch report is related to 2122870-2012-01720.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01721 |
| MDR Report Key | 2718535 |
| Report Source | 05,06 |
| Date Received | 2012-08-28 |
| Date of Report | 2012-08-07 |
| Date of Event | 2012-08-07 |
| Date Mfgr Received | 2012-08-07 |
| Device Manufacturer Date | 2011-07-23 |
| Date Added to Maude | 2012-12-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNICEL? DXI 800 ACCESS? IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-08-28 |
| Model Number | NA |
| Catalog Number | 973100 |
| Lot Number | NA |
| ID Number | SOFTWARE VERSION 4.4 |
| 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 | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-28 |