MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-02-03 for ALT (ALANINE AMINOTRANSFERASE) IFCC 467840 manufactured by Beckman Coulter, Inc..
[2562027]
On (b)(4) 2012, customer reported that 2 cartridges of alanine aminotransferase (alt) reagent were leaking upon arrival and appeared to have a defect along the bottom seam of the cartridge. No exposure or injuries were reported and no erroneous patient results were generated. It was decided that an mdr should be filed because the reagent contains material of animal origin that is potentially infectious, and upon recur, exposure could result in serious injury.
Patient Sequence No: 1, Text Type: D, B5
[9618848]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00362 |
| MDR Report Key | 2438831 |
| Report Source | 01,06 |
| Date Received | 2012-02-03 |
| Date of Report | 2012-01-18 |
| Date of Event | 2012-01-18 |
| Date Mfgr Received | 2012-01-18 |
| Device Manufacturer Date | 2011-06-07 |
| Date Added to Maude | 2012-08-13 |
| 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 SOUTH 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 | ALT (ALANINE AMINOTRANSFERASE) IFCC |
| Generic Name | NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
| Product Code | CKA |
| Date Received | 2012-02-03 |
| Catalog Number | 467840 |
| Lot Number | T106012 |
| Device Expiration Date | 2012-12-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-03 |