MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-05 for ACCESS 2 IMMUNOASSAY SYSTEM N/A 81600N manufactured by Beckman Coulter Inc..
[1626770]
A customer contacted beckman coulter inc. (bci) in regards to erroneous elevated ckmb result generated by access 2 immunoassay analyzer. Patient sample was repeated on an alternate unit and normal ckmb result was obtained. The erroneous result was not reported out of the laboratory. Patient treatment was not impacted by this event.
Patient Sequence No: 1, Text Type: D, B5
[8677085]
The sample was collected in li heparin plasma tubes with a gel separator and centrifuged for six minutes at 3000 rpm. Qc was within the lab's established ranges pre and post the event. The customer performed a routine system check on (b)(4) 2010 which failed the washed mean. Bci field service engineer (fse) cleaned and verified the unit is working properly. Fse did not note any issues with the unit. A clear root cause of this event can not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2010-00399 |
| MDR Report Key | 1786665 |
| Report Source | 05 |
| Date Received | 2010-08-05 |
| Date of Report | 2010-08-04 |
| Date of Event | 2010-07-14 |
| Date Mfgr Received | 2010-07-14 |
| Device Manufacturer Date | 2001-05-03 |
| 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 | ACCESS 2 IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2010-08-05 |
| Model Number | N/A |
| Catalog Number | 81600N |
| 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 | 2010-08-05 |