MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-30 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter.
[16551259]
The customer reported discovering a leak under the sample wheel of the immage 800 immunochemistry system. The customer could not identify the source of the leak and had requested for service to evaluate the instrument. The customer stated that approximately 10 ml of fluid leaked and was contained within the instrument. The customer was wearing personal protective equipment consisting of a laboratory coat, gloves, and eye protection at the time of the event and no injury or exposure was reported. No erroneous patient results were generated and there was no change or affect to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[16846435]
A beckman coulter field service engineer (fse) was dispatched to the customer's site. The fse discovered a leak at the t fitting which supplies wash solution to sample and reagent syringe valve. The fse proceeded to re-tighten the fitting to resolve the leak and verified repair per established procedures. Failure mode of the leak is attributed to a loose t fitting. Results: t fitting. Beckman coulter internal identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2013-00530 |
| MDR Report Key | 3255435 |
| Report Source | 05,06 |
| Date Received | 2013-07-30 |
| Date of Report | 2013-07-11 |
| Date of Event | 2013-07-11 |
| Date Mfgr Received | 2013-07-11 |
| Device Manufacturer Date | 2013-04-09 |
| Date Added to Maude | 2013-10-24 |
| 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 |
| Manufacturer G1 | BECKMAN COULTER |
| 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, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2013-07-30 |
| Model Number | NA |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SW VERSION 1.6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-30 |