MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-05 for MICROGENICS DRI BARBITURATE SERUM TOX ASSAY * 0911 manufactured by Microgenics Corporation.
[20935708]
Dri serum tox barbiturates analysis. The package insert states that a concentration of pentobarbitol at 5 ug/ml produces a positive result. Patient's sample was tested on in-house screen and it was negative. Repeat testing showed it was barely positive. The results reported from the reference lab was 28ug/ml. Original sample sent to microgenics for testing with dri serum tox barbiturates assay confirming our results. The sample result was negative and the reference lab confirmation for pentobarbitol by gcms was 5. 7ug/ml
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 778326 |
| MDR Report Key | 778326 |
| Date Received | 2006-10-05 |
| Date of Report | 2006-10-05 |
| Date of Event | 2006-07-17 |
| Report Date | 2006-10-05 |
| Date Reported to FDA | 2006-10-05 |
| Date Added to Maude | 2006-11-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROGENICS DRI BARBITURATE SERUM TOX ASSAY |
| Generic Name | SERUM NEGATIVE CALIBRATER |
| Product Code | DIS |
| Date Received | 2006-10-05 |
| Returned To Mfg | 2006-01-01 |
| Model Number | * |
| Catalog Number | 0911 |
| Lot Number | REAGENT LOT 56561925 |
| ID Number | * |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 766096 |
| Manufacturer | MICROGENICS CORPORATION |
| Manufacturer Address | 46360 FREMONT BLVD FREMONT CA 94538 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-05 |