MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-04-01 for ARCHITECT BENZODIAZEPINE 1E16-20 manufactured by Abbott Manufacturing, Inc..
[811915]
An abbott rep stated that a pt was admitted to the er in 2008, for a suspected drug overdose. The pt sample was tested for a complete drug screen ( all tests not provided), with all results being negative. The next day, a second sample tested negative. The er doctor questioned the benzo results and requested the sample be sent out for confirmation. While awaiting the test result the doctor proceeded with the benzo overdose treatment. The confirmatory test results for both samples tested positive (3000 ng/ml) for lorazepam. The abbott rep at the facility reran the samples on many dilutions and all results were architect benzo negative. The sample is being sent out for alternate benzo testing. The account believes to have a false negative benzo result and is questioning if the architect benzo assay is detecting lorazepam rather than benzo. There was no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5
[8048803]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2008-00038 |
| MDR Report Key | 1023859 |
| Report Source | 07 |
| Date Received | 2008-04-01 |
| Date of Report | 2008-03-06 |
| Date of Event | 2008-02-28 |
| Date Mfgr Received | 2008-03-06 |
| Date Added to Maude | 2008-11-14 |
| 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 | SUDARSHAN HEBBAR, MD, D-3MQC, AP6B |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479379677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT BENZODIAZEPINE |
| Generic Name | QUANTITATIVE ANALYSIS OF BENZODIAZEPINE IN HUMAN URINE |
| Product Code | JXM |
| Date Received | 2008-04-01 |
| Model Number | NA |
| Catalog Number | 1E16-20 |
| Lot Number | 53041HW00 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1021470 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-01 |