MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-25 for ABBOTT VANCOMYCIN ASSAY 6E44-21 manufactured by Microgenics Corporation.
[101151144]
The customer began using a new lot of vancomycin reagent lot 71368fd01. Prior to accepting the use of the new reagent lot, the customer calibrated and ran qc along with some archived patent samples to check the performance. Qc results were all in range with both lots. The customer had a couple of leftover patient samples with original values (on previous reagent lot 71346fd01) that were in the 31-34 ug/ml range. The customer decided to rerun leftover customer samples in parallel on the new and the old reagent lots. Customer observed low result of <1. 1ug/ml only on the new reagent lot. Customer diluted the sample and tested it again on the new reagent lot and obtained a result of 29 ug/ml customer concluded that the discrepancy is within the patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010939897-2018-00001 |
| MDR Report Key | 7295374 |
| Date Received | 2018-02-25 |
| Date of Report | 2017-02-02 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2017-08-07 |
| Date Added to Maude | 2018-02-25 |
| 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 | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID 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 | ABBOTT VANCOMYCIN ASSAY |
| Generic Name | VANCOMYCIN TEST SYSTEM |
| Product Code | LEH |
| Date Received | 2018-02-25 |
| Returned To Mfg | 2018-01-11 |
| Model Number | 6E44-21 |
| Catalog Number | 6E44-21 |
| Lot Number | 71368FD01 |
| Device Expiration Date | 2019-02-07 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-25 |