MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for MULTIGENT ABBOTT VANCOMYCIN ASSAY 6E44-21 manufactured by Microgenics Corporation.
[112284026]
Ivd test for vancomycin for a transplant patient revealed unusually low result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010939897-2018-00002 |
| MDR Report Key | 7605896 |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-05-31 |
| Date Added to Maude | 2018-06-15 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVE SCHULTENOVER |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MULTIGENT ABBOTT VANCOMYCIN ASSAY |
| Generic Name | VANCOMYCIN TEST SYSTEM, |
| Product Code | LEH |
| Date Received | 2018-06-15 |
| Model Number | 6E44-21 |
| Catalog Number | 6E44-21 |
| 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 | 2018-06-15 |