MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-06 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM IMMAGE 800 A15445 manufactured by Beckman Coulter Inc..
[2463444]
Customer called on (b)(6) 2011 reporting of a fluid leak inside the immage 800 immunochemistry system. Customer stated that dried wash buffer was also found near the sample probe and under the instrument. Customer technical support (cts) advised customer the use of proper personal protective equipment before troubleshooting and instructed customer to check for active leaks at the probes and syringes but none were found. Cts also instructed customer to prime and check for further leaks and customer found pooled liquid under the reagent syringe assembly. No exposure or injury was reported as a result of the leak and patient results were not affected. Field service engineer (fse) spoke with the customer on the phone and the customer stated that they found 3 way valve fitting loose causing wash buffer to pool. Fse had the customer to remove the front cover and tightened fittings on valve assembly.
Patient Sequence No: 1, Text Type: D, B5
[9568873]
Evaluation - method: troubleshooting was done over the phone. Evaluation - results: customer removed the front cover and tightened fittings on valve assembly. (b)(4). Troubleshooting was done over the phone.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-08252 |
| MDR Report Key | 2360646 |
| Report Source | 05,06 |
| Date Received | 2011-12-06 |
| Date of Report | 2011-11-14 |
| Date of Event | 2011-11-14 |
| Date Mfgr Received | 2011-11-14 |
| Device Manufacturer Date | 2007-10-16 |
| Date Added to Maude | 2012-07-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2011-12-06 |
| Model Number | IMMAGE 800 |
| Catalog Number | A15445 |
| ID Number | SW VERSION 2.0 |
| 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 | 2011-12-06 |