MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-06 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Alere San Diego, Inc..
[2232463]
Caller reported a potential (b)(4) result on one patient. Physician's office called to report a patient that tested (b)(4) for opiate and tca. They wanted to know why the tox screen was not (b)(4) for acetaminophen when she was taking tylenol 3.
Patient Sequence No: 1, Text Type: D, B5
[9379068]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2011-02084 |
| MDR Report Key | 2321756 |
| Report Source | 05,06 |
| Date Received | 2011-10-06 |
| Date of Report | 2011-10-06 |
| Date of Event | 2011-09-14 |
| Date Mfgr Received | 2011-09-14 |
| Date Added to Maude | 2011-12-20 |
| 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 | URINE DRUG SCREEN TEST |
| Product Code | DJR |
| Date Received | 2011-10-06 |
| Model Number | 94400 |
| Lot Number | W49317B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-06 |