MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-12 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[2938741]
The customer reported an uncontained fluid leak underneath the immage 800 immunochemistry systems, which leaked onto the counter top. Per customer this is a new instrument and they have not run patient samples only quality controls on it. The customer was wearing personal protective equipment (ppe) consisting of a lab coat, eye protection, and gloves. The customer did not come in contact with the fluid and did not seek medical attention. No injury or exposure (sprayed or splashed) to mucous membranes or open wounds were reported.
Patient Sequence No: 1, Text Type: D, B5
[10300545]
On (b)(4) 20128, a field service engineer (fse) was on site and found a loose connection between the wash buffer supply and the syringe selector valve. The fse secured the fitting internal probe wash assembly. The failure mode of leak was the loose fitting internal prove wash assembly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01821 |
| MDR Report Key | 2828157 |
| Report Source | 05,06 |
| Date Received | 2012-11-12 |
| Date of Report | 2012-10-17 |
| Date of Event | 2012-10-17 |
| Date Mfgr Received | 2012-10-17 |
| Device Manufacturer Date | 2012-07-26 |
| Date Added to Maude | 2013-02-15 |
| 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 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2012-11-12 |
| Catalog Number | A15445 |
| Lot Number | N/A |
| ID Number | SW 4.0 |
| 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 | 2012-11-12 |