MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-03-16 for IMMAGE IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[18805701]
The customer did not report any system errors or issues with other chemistries. The customer indicated that quality control results are acceptable. Cause of the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[18979380]
The customer reported obtaining more rheumatoid factor (rf) results > 20 iu/ml on the immage immunochemistry system when using new rf reagent lot m012376. The customer did not provide information on patients nor samples. No injury or change to patient treatment was reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2012-00548 |
| MDR Report Key | 2493750 |
| Report Source | 01,05,06 |
| Date Received | 2012-03-16 |
| Date of Report | 2011-12-04 |
| Date of Event | 2011-11-24 |
| Date Mfgr Received | 2011-12-04 |
| Device Manufacturer Date | 2011-04-19 |
| Date Added to Maude | 2012-08-27 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE IMMUNOCHEMISTRY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | DHR |
| Date Received | 2012-03-16 |
| Model Number | NA |
| Catalog Number | A15445 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-03-16 |