MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-02 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter Inc..
[2194777]
The customer contacted beckman coulter, inc (bci) in regards to erroneously elevated accutni (troponin i) results generated on the access 2 immunoassay system seven pts. The pt samples were retested at an alternate site and the results were within the normal reference range. The initial erroneously elevated results were reported outside the laboratory. There are no reports or any adverse pt consequence or any medical intervention to prevent or preclude any adverse pt event.
Patient Sequence No: 1, Text Type: D, B5
[9471790]
The field service engineer (fse) was dispatched to the site on (b)(4) 2008 to investigate the event. The fse performed preventative maintenance on in the instrument, changed the seals in the precision and wash pump, flushed the wash buffer reservoir, and ran lumwash son/inc. The fse also ran accutni precision testing. No hardware issues were noted. A definitive root cause could not be determined for this event. This is 2 of 3 separate mdr reports related to 7 pts events associated with a single malfunction report on different days. Reference mdr numbers 2122870-2011-03347, 03348, 03349 for all related events. This reportable event was identified during a retrospective review of complaints conducted between (b)(4), 2008 through (b)(4), 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-03348 |
| MDR Report Key | 2258885 |
| Report Source | 05,06 |
| Date Received | 2011-09-02 |
| Date of Report | 2008-12-22 |
| Date of Event | 2008-12-23 |
| Date Mfgr Received | 2008-12-22 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2012-06-07 |
| 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 |
| Generic Name | JJE |
| Product Code | CGN |
| Date Received | 2011-09-02 |
| 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 DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-02 |