MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-12 for SYNCHRON? TG REAGENT KIT, 2 X 300 TESTS 445850 manufactured by Beckman Coulter, Inc..
[15539906]
A customer reported to beckman coulter, inc. (bec) a leak from synchron tg (triglyceride) reagent kit. There was no exposure to uncovered wounds or mucous membranes. No injury was reported. There was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[15866820]
There was leakage from the compartment b of the reagent cartridge. The kit box showed signs of leakage and mold growth. Beckman coulter, inc. (bec) received a photograph of the affected reagent kit. A replacement kit was sent to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02547 |
| MDR Report Key | 2159249 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-12 |
| Date of Report | 2011-06-10 |
| Date of Event | 2011-06-09 |
| Date Mfgr Received | 2011-06-10 |
| Device Manufacturer Date | 2010-08-03 |
| Date Added to Maude | 2011-09-23 |
| 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. 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 | SYNCHRON? TG REAGENT KIT, 2 X 300 TESTS |
| Generic Name | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES |
| Product Code | CDT |
| Date Received | 2011-07-12 |
| Catalog Number | 445850 |
| Lot Number | M006745 |
| ID Number | NI |
| Device Expiration Date | 2012-02-29 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-07-12 |