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 2012-01-24 for SYNCHRON? ALANINE AMINOTRANSFERASE (ALT) 2 X 400 REAGENT KIT CX/LX ALT KIT 176826 manufactured by Beckman Coulter Inc..
[2560382]
A customer contacted beckman coulter inc. (bec) stating that upon receipt of the synchron alanine aminotransferase (alt) 2 x 400 reagent lot, the customer observed that one (1) reagent kit was empty and wet with no visible damage. No injury or operator exposure was reported for this event.
Patient Sequence No: 1, Text Type: D, B5
[9700220]
The customer was sent a replacement. Bec identifier for this report is (b)(4). Defected device was replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00253 |
| MDR Report Key | 2426949 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-24 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-11-04 |
| Date Mfgr Received | 2011-11-04 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-08-08 |
| 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 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| 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? ALANINE AMINOTRANSFERASE (ALT) 2 X 400 REAGENT KIT |
| Generic Name | NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
| Product Code | CKA |
| Date Received | 2012-01-24 |
| Model Number | CX/LX ALT KIT |
| Catalog Number | 176826 |
| Lot Number | M102143 |
| ID Number | NA |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-24 |