MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-15 for SYNCHRON? SYSTEMS GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT GGT REAGENT 442650 manufactured by Beckman Coulter Inc..
[2352014]
Customer called on (b)(6) 2011 stating that when they switched to ggt lot m103353 on (b)(6) 2011 for a unicel dxc 800 synchron system, their qc shifted high. Customer ran a patient study and the patient results shifted high as well. Customer had received a new lot m105340 and their qc runs were acceptable again. Customer reported that they will use lot m105340 for running patient samples. Erroneous patient results generated during the study was not reported out of the lab.
Patient Sequence No: 1, Text Type: D, B5
[9486204]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07631 |
| MDR Report Key | 2337624 |
| Report Source | 05,06 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-10-20 |
| Date of Event | 2011-10-19 |
| Date Mfgr Received | 2011-10-20 |
| Device Manufacturer Date | 2011-04-20 |
| Date Added to Maude | 2012-07-16 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? SYSTEMS GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT |
| Generic Name | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE |
| Product Code | JPZ |
| Date Received | 2011-11-15 |
| Model Number | GGT REAGENT |
| Catalog Number | 442650 |
| Lot Number | M103353 |
| Device Expiration Date | 2012-06-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |