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 2012-01-19 for SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT 442635 manufactured by Beckman Coulter, Inc..
[21980199]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[22238868]
Customer reported to beckman coulter, inc. (bec) that when she tried to open the lid of a new creatine kinase (ck) reagent, she discovered that the reagent had leaked from the compartments b and c. There was no report of erroneous results generated. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2012-00189 |
| MDR Report Key | 2421606 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-19 |
| Date of Report | 2011-12-27 |
| Date of Event | 2011-12-27 |
| Date Mfgr Received | 2011-12-27 |
| Device Manufacturer Date | 2011-06-10 |
| Date Added to Maude | 2012-08-07 |
| 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 | 7149613634 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT |
| Generic Name | NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
| Product Code | CKA |
| Date Received | 2012-01-19 |
| Catalog Number | 442635 |
| Lot Number | M104450 |
| Device Expiration Date | 2012-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-19 |