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 2012-01-10 for CX ALANINE AMINOTRANSFERASE REAGENT CARTRIDGE ALT REAGENT 467840 manufactured by Beckman Coulter, Inc..
[19676837]
Customer called to report that while unpacking a shipment of cx alanine aminotransferase (alt) reagent cartridge, lot #t106012, one of the reagent kits appeared to be leaking. Upon further inspection, customer discovered that one cartridge in the alt kit was, in fact, leaking. There did not appear to be any damage to the cartridge or the shipment box. The leak appeared to be coming from the base of the cartridge, where the side of the cartridge is fused to the base. Customer stated that no one was harmed, injured or exposed to the leak.
Patient Sequence No: 1, Text Type: D, B5
[19751698]
The reagent cartridge was not returned by customer, and credit was issued to customer's account for the defective, leaking shipment. (b)(4). Customer did not return shipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00075 |
| MDR Report Key | 2408138 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-10 |
| Date of Report | 2011-12-09 |
| Date of Event | 2011-12-09 |
| Date Mfgr Received | 2011-12-09 |
| Device Manufacturer Date | 2011-06-07 |
| Date Added to Maude | 2012-06-19 |
| 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 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CX ALANINE AMINOTRANSFERASE REAGENT CARTRIDGE |
| Generic Name | NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
| Product Code | CKA |
| Date Received | 2012-01-10 |
| Model Number | ALT REAGENT |
| Catalog Number | 467840 |
| Lot Number | T106012 |
| Device Expiration Date | 2012-12-31 |
| 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. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-10 |