MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-18 for ABBOTT VANCOMYCIN ASSAY 6E44-21 manufactured by Microgenics Corporation.
[95925185]
(b)(6). Customer is not willing to give patient information or if treatment was given. Both tubes were plasma spun at 10 min at 5000 rpm. On (b)(6) 2017 t19:16:43z : chatfam : : new lot of cal and rtg being sent in for trouble shooting ncchatfam (b)(6) 2017 1420.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010939897-2017-00004 |
| MDR Report Key | 7124389 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2017-12-01 |
| Device Manufacturer Date | 2017-05-19 |
| Date Added to Maude | 2017-12-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR PATRICK LYNCH |
| Manufacturer Street | 46500 KATO ROAD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5109795000 |
| Manufacturer G1 | MICROGENICS CORPORATION |
| Manufacturer Street | 46500 KATO ROAD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT VANCOMYCIN ASSAY |
| Generic Name | VANCOMYCIN TEST SYSTEM, PRODUCT CODE: LEH |
| Product Code | LEH |
| Date Received | 2017-12-18 |
| Model Number | 6E44-21 |
| Catalog Number | 6E44-21 |
| Lot Number | 713346FD01 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROGENICS CORPORATION |
| Manufacturer Address | 46500 KATO ROAD FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-18 |