MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-19 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM N/A A15445 manufactured by Beckman Coulter Inc..
[21020647]
The customer reported that the sample wash station of the immage 800 immunochemistry system was intermittently overflowing. The customer indicated that 1 ml of fluid had overflowed while in normal operating mode and no vacuum errors were generated. The customer was wearing personal protective equipment consisting of a lab coat, gloves and eye protection and no exposure or injury was reported. The customer stated that no erroneous results were generated and there was no change to patient treatment in connection with the event. Beckman coulter field service engineer (fse) was dispatched and found a loose fitting on the vacuum line going to the cup. The fse secured the fitting and repair was verified per established procedures. Failure mode was determined to be a loose fitting.
Patient Sequence No: 1, Text Type: D, B5
[21309978]
Results: loose fitting. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01862 |
| MDR Report Key | 2838911 |
| Report Source | 05,06 |
| Date Received | 2012-11-19 |
| Date of Report | 2012-10-31 |
| Date of Event | 2012-10-31 |
| Date Mfgr Received | 2012-10-31 |
| Device Manufacturer Date | 2008-09-23 |
| Date Added to Maude | 2013-02-26 |
| 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 | 2012-11-19 |
| Model Number | N/A |
| Catalog Number | A15445 |
| ID Number | SW VERSION 1.9 |
| 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 | 2012-11-19 |