MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-04 for IMMAGE 800 IMMUNOCHEMISTRY SYSTEM N/A A15445 manufactured by Beckman Coulter Inc..
[16097412]
The sample was serum. Qc controls were within established ranges. Customer reported that the unit was recalibrated. Bci field service engineer has not been requested by the customer as of 06/02/2010. A clear root cause cannot be determined for this event.
Patient Sequence No: 1, Text Type: N, H10
[16170156]
A customer contacted beckman coulter inc. (bci) to report an erroneous normal igg result, which was generated by image 800 chemistry analyzer. The sample was repeated and correct results were obtained. An amended report was issued. The low result was reported out of the laboratory. Patient treatment was not impacted with regard to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2010-00297 |
| MDR Report Key | 1710737 |
| Report Source | 05 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-06-04 |
| Date of Event | 2010-05-04 |
| Date Mfgr Received | 2010-05-04 |
| Device Manufacturer Date | 2008-09-22 |
| Date Added to Maude | 2010-11-10 |
| 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 | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER/IMMUNOCHEMISTRY SYSTEMS |
| Product Code | CFN |
| Date Received | 2010-06-04 |
| Model Number | N/A |
| Catalog Number | A15445 |
| Lot Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-04 |