MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-23 for IMMAGE 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter Inc..
[2117361]
A customer contacted beckman coulter inc. (bci) in regards to an erroneous low microalbumin (ma) two patients generated by the image 800 immunochemistry. The erroneous results were reported out of the laboratory. The initial patient samples were repeated and higher results were obtained. Amended reports were initiated. The customer has not received any reports of affects to patients due to the incorrect results.
Patient Sequence No: 1, Text Type: D, B5
[9166955]
The samples were urine. The customer did not note any sample or system issue(s). On (b)(4) 2011, a bci field service engineer (fse) found air in sample probe tube and wash station filled. Fse flushed both proves thru valves. Steam was emitting from the reagent probe, which indicates a blockage. Fse aligned and replaced the cuvette wash head teflon which was coated with dried buffer. Replaced filter on cuvette wash drain line. Igg precision run at 2. 04% cv. Instrument is operating acceptably now.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02219 |
| MDR Report Key | 2137636 |
| Report Source | 06 |
| Date Received | 2011-06-23 |
| Date of Report | 2011-03-30 |
| Date of Event | 2011-03-26 |
| Date Mfgr Received | 2011-03-30 |
| Device Manufacturer Date | 2007-12-24 |
| Date Added to Maude | 2012-02-27 |
| 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 |
| 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 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER/IMMUNOCHEMISTRY SYSTEMS |
| Product Code | JQX |
| Date Received | 2011-06-23 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-06-23 |