MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-28 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter.
[4095095]
A customer stated that the sample syringe was cracked and leaking on top of their image 800 instrument. The leaking fluid that the customer found was diluted patient sample. No erroneous patient results were generated due to this event. In addition, no biohazard exposure or injury occurred due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11540722]
A field service engineer (fse) called the customer and determined that the syringe barrel was completely snapped out from its fitting, causing the leak. The service engineer sent a new barrel to the customer to resolve the issue. On the following day, the service engineer called the customer and confirmed that the instrument qc was running without any further issue. This failure mode has a potential to impact patient results. The manufacturer reference number for this event is (b)(4). Customer resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2014-00039 |
| MDR Report Key | 3596192 |
| Report Source | 05,06 |
| Date Received | 2014-01-28 |
| Date of Report | 2014-01-09 |
| Date of Event | 2014-01-09 |
| Date Mfgr Received | 2014-01-09 |
| Device Manufacturer Date | 2010-09-13 |
| Date Added to Maude | 2014-04-22 |
| 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 |
| 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 | 2014-01-28 |
| Model Number | NA |
| Catalog Number | A15445 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-01-28 |