MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-02 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[17197127]
A customer reported to beckman coulter, inc. (bec) a fluid leak on immage 800 immunochemistry system. The customer has a hazard management plan in place. There was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[17320832]
Service visited on (b)(4) 2011, and the field service engineer (fse) found wash head filter occluded with some black material and wash head overflowing cuvettes. The fse replaced filter and performed wash cuvettes, which resulted in no leak or overflow. The fse cleaned up spillage and replaced cuvettes as they were saturated with wash solution externally. There was no further instrument leak complaint filed as of (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02537 |
| MDR Report Key | 2148219 |
| Report Source | 06 |
| Date Received | 2011-07-02 |
| Date of Report | 2011-06-02 |
| Date of Event | 2011-06-02 |
| Date Mfgr Received | 2011-06-02 |
| Device Manufacturer Date | 2010-12-02 |
| Date Added to Maude | 2012-03-15 |
| 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 | 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2011-07-02 |
| Catalog Number | A15445 |
| Lot Number | NA |
| ID Number | SW 2.0 |
| 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 | 2011-07-02 |