MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-11 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter Inc..
[2025610]
A customer contacted beckman coulter inc. (bci) to report elevated ck-mb results above the normal reference range for two patients generated by the access 2 immunoassay analyzer. The results were not reported out of the laboratory. The samples were repeated on an alternate unit and lower results within the normal reference range were obtained. No reports of death, injury, or change to patient treatment have been reported in connection with this event
Patient Sequence No: 1, Text Type: D, B5
[9124418]
Sample and centrifugation information was not provided. On (b)(4) 2011 system check was performed which passed within specifications. Per customer, the system was displaying wash valve/pump motion errors. A bci field service engineer (fse) found the buffer line crimped between the access and fluidics tray. Fse replaced the buffer clamp, the original clamp was missing. Fse performed verification testing which passed within specifications. Although hardware issues were addressed, a definitive root cause could not be determined for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01355 |
| MDR Report Key | 2083861 |
| Report Source | 06 |
| Date Received | 2011-05-11 |
| Date of Report | 2011-04-11 |
| Date of Event | 2011-04-11 |
| Date Mfgr Received | 2011-04-11 |
| Device Manufacturer Date | 2001-05-14 |
| Date Added to Maude | 2011-09-21 |
| 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 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2011-05-11 |
| Model Number | ACCESS 2 |
| Catalog Number | 81600N |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-05-11 |