MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-05-10 for ACCESS 2 IMMUNOASSAY SYSTEM ACCESS2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[470272]
Erroneously elevated troponin (accu tnl) result from a single pt sample that was generated by the access 2 instrument. An initial was reported out of the lab and questioned by the physician. On the same day, the pt original sample was re-tested for accu tnl. The repeated accu tnl result was 0. 03ng/ml. The customer did not received any report of pt injury requiring med intervention or change to pt treatment attributed to or connected to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2006-00108 |
| MDR Report Key | 713166 |
| Report Source | 05 |
| Date Received | 2006-05-10 |
| Date of Report | 2006-05-10 |
| Date of Event | 2006-04-18 |
| Date Mfgr Received | 2006-04-19 |
| Device Manufacturer Date | 2004-12-01 |
| Date Added to Maude | 2006-05-16 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ERI HIRUMI, GROUP MGR |
| Manufacturer Street | 200 S. KRAEMER BLVD P.O. BOX 8000 |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149614389 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | JJJ |
| Date Received | 2006-05-10 |
| Model Number | ACCESS2 IMMUNOASSAY SYSTEM |
| Catalog Number | 81600N |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 702235 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DR. CHASKA MN 55318 US |
| Baseline Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
| Baseline Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Baseline Model No | IMUNOASSAY SYST |
| Baseline Catalog No | 81600N |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-10 |