MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-12-20 for SYNCHRON? TRIGLYCERIDES REAGENT 445850 manufactured by Beckman Coulter Inc..
[16424152]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[16533707]
A customer contacted beckman coulter inc. (bec) stating that the synchron triglycerides reagent container they received was cracked and damaged and therefore leaking. The reagent lot number is z105223 which is not distributed in the united states, however, they are the same cartridges and caps that are used in the united states. No injury or exposure was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2011-08508 |
| MDR Report Key | 2383257 |
| Report Source | 01,06 |
| Date Received | 2011-12-20 |
| Date of Report | 2011-11-29 |
| Date of Event | 2011-11-29 |
| Date Mfgr Received | 2011-11-29 |
| Device Manufacturer Date | 2011-05-26 |
| Date Added to Maude | 2012-07-25 |
| 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. 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? TRIGLYCERIDES REAGENT |
| Generic Name | TRIGLYCERIDE TEST SYSTEM |
| Product Code | CDT |
| Date Received | 2011-12-20 |
| Model Number | NA |
| Catalog Number | 445850 |
| Lot Number | Z105223 |
| ID Number | NI |
| 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 | 2011-12-20 |