MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-06-01 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Biosite Incorporated.
[1541272]
Caller reported discrepant results for coc and apap on triage tox drug screen with mtd. Customer was notified by technicians that they have seen discrepant results on coc and apap for tox drug screen in the emergency room when the sample is repeated on a new device. One sample went from positive to negative coc. One sample went from negative to positive coc. One sample had discrepant results for apap, but the caller is not sure if it went from positive to negative or vice versa. Customer has no info on pt's (medical history, medication, etc. ).
Patient Sequence No: 1, Text Type: D, B5
[8547323]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2010-00687 |
| MDR Report Key | 1713463 |
| Report Source | 05,06 |
| Date Received | 2010-06-01 |
| Date of Report | 2010-06-01 |
| Date of Event | 2010-05-10 |
| Date Mfgr Received | 2010-05-10 |
| Date Added to Maude | 2010-08-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMEN BERGELIN, MANAGER |
| Manufacturer Street | 9975 SUMMERS RIDGE RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE TOX DRUG SCREEN WITH MTD |
| Generic Name | TOX DRUG SCREEN |
| Product Code | DJR |
| Date Received | 2010-06-01 |
| Model Number | 94400 |
| Catalog Number | 94400 |
| Lot Number | W47245 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE INCORPORATED |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-01 |