MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-09 for IMMAGE? IMMUNOCHEMISTRY SYSTEM 470000 manufactured by Beckman Coulter Inc..
[21426377]
A customer contacted beckman coulter inc. (bec) stating that the samples and reagent probe wash stations in the immage immunochemistry system were not draining and were overflowing. No injury or exposure was reported and no erroneous results were generated.
Patient Sequence No: 1, Text Type: D, B5
[21535680]
The customer performed troubleshooting with bec cts (customer technical support) and noted that the sample and reagent probe wash stations were not draining and overflowing as a result of a lack of vacuum. Cts generated a service request. A field service engineer (fse) went on-site (b)(4) 2011 and replaced a diaphragm due to the low vacuum issue. Repair was verified per established procedures and results met published performance specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-05090 |
| MDR Report Key | 2240188 |
| Report Source | 05,06 |
| Date Received | 2011-09-09 |
| Date of Report | 2011-08-11 |
| Date of Event | 2011-08-11 |
| Date Mfgr Received | 2011-08-11 |
| Device Manufacturer Date | 2010-06-04 |
| Date Added to Maude | 2012-05-25 |
| 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 | 7168282419 |
| 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? IMMUNOCHEMISTRY SYSTEM |
| Generic Name | CLINICAL CHEMISTRY, NEPHELOMETER |
| Product Code | JQX |
| Date Received | 2011-09-09 |
| Model Number | IMMAGE |
| Catalog Number | 470000 |
| 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 INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-09 |