MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2011-07-26 for SYNCHRON? ALT REAGENT, 2 X 200 TEST 442620 manufactured by Beckman Coulter, Inc..
[2127298]
An employee of beckman coulter at (b)(4) report a fluid leak from synchron alt (alanine aminotransferase) reagent. The leak was found during receiving inspection, and the operator was wearing ppe. There was no exposure to uncovered wounds or mucous membranes. No injury was reported msds was reviewed, and the facility has exposure control plan. Medical attention was not sought and there was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[9243434]
Bec evaluated the photographs of the affected reagent cartridge and kit box. Liquid was visible on alt reagent cartridge although there was no loosening of the cap. The shipping box contained another reagent, synchron chol (cholesterol) reagent, which had loose cap and leaked. This reagent is non-hazardous. It is possible that the leak was from chol reagent and not from alt, but could not be confirmed. Note: listed below is information regarding synchron chol reagent: catalogue number: 467825, lot number: m101676, date of manufacturing: 02/24/2011, expiration date: 02/29/2012, 510(k): k971505. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03626 |
| MDR Report Key | 2178375 |
| Report Source | 00,01 |
| Date Received | 2011-07-26 |
| Date of Report | 2011-06-21 |
| Date of Event | 2011-06-21 |
| Date Mfgr Received | 2011-06-21 |
| Device Manufacturer Date | 2011-03-04 |
| Date Added to Maude | 2012-04-16 |
| 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 | 0 |
| 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? ALT REAGENT, 2 X 200 TEST |
| Generic Name | NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
| Product Code | CKA |
| Date Received | 2011-07-26 |
| Catalog Number | 442620 |
| Lot Number | M102250 |
| ID Number | NI |
| Device Expiration Date | 2012-09-30 |
| 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 | 2011-07-26 |