MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-20 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[2019605]
The customer contacted beckman coulter inc. , (bci) on (b)(6) 2008 regrading elevated accutni (troponin) results on eight different patients. Results were generated on the access 2 immunoassay system. The customer re-ran the samples on a different instrument in the lab and all the results were negative. The initial elevated accutni results were reported outside the laboratory. Its unknown if there is any reports of any adverse patient consequence or change to the patients' treatment. There are no indications of any medical intervention to prevent or preclude any adverse patient event. This report refers to patient number two.
Patient Sequence No: 1, Text Type: D, B5
[8983570]
Field service engineer (fse) was dispatched on site on (b)(4) 2008 to investigate the event. Fse noted that the instrument has a preventative maintenance (pm) performed on it on (b)(4) 2008. The fse noted that a system check, high sensitivity system check, and precision runs all passed within instrument and assay specifications. No definitive root cause can be determined from this event. This is one of eight separate mdr reports related to eight patients event associated with a single malfunction report. Reference mdr numbers 2122870-2011-01154, -01157, -01227, -01228, -01229, -01230, -01231 for all related events. This reportable event was identified during a retrospective review of complaints conducted between (b)(4) 2008 and (b)(4), 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01156 |
| MDR Report Key | 2121831 |
| Report Source | 05,06 |
| Date Received | 2011-05-20 |
| Date of Report | 2008-11-23 |
| Date of Event | 2008-11-22 |
| Date Mfgr Received | 2008-11-23 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2012-03-30 |
| 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 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 DR. |
| 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 | ACCESS 2 IMMUNOASSAY SYSTEM |
| Product Code | CGN |
| Date Received | 2011-05-20 |
| Model Number | NA |
| Catalog Number | 81600N |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DR. CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-20 |