MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-10 for BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT TRIGLYCERIDE REAGENT 445850 manufactured by Beckman Coulter Inc..
[2314665]
Customer called on (b)(6) 2011 reporting that a box of beckman sychron(tm) triglycerides reagents had leaked during shipment. Customer reported that there was no apparent damage to the box and did not know whether the leak may have been attributed to loose caps.
Patient Sequence No: 1, Text Type: D, B5
[9561107]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-08432 |
| MDR Report Key | 2365458 |
| Report Source | 05,06 |
| Date Received | 2011-12-10 |
| Date of Report | 2011-11-23 |
| Date of Event | 2011-11-23 |
| Date Mfgr Received | 2011-11-23 |
| Device Manufacturer Date | 2011-02-28 |
| Date Added to Maude | 2012-07-23 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT |
| Generic Name | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES |
| Product Code | CDT |
| Date Received | 2011-12-10 |
| Model Number | TRIGLYCERIDE REAGENT |
| Catalog Number | 445850 |
| Lot Number | M011745 |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2011-12-10 |