MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2011-08-10 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Alere San Diego, Inc..
[2196772]
Caller alleged false negative apap. Pt tested apap negative and opi positive. Pt is taking vicodin 5mg (hydrocodone) /500mg (apap), 1 qid. On (b)(6) 2011, urine was tested at 9:20am with tox w48841b, apap - and opi +. All controls passed ok. No abnormality was observed on urine sample. No urine sample was saved. No info on pt's clinical condition and diagnosis was provided. The lab is using tox to monitor pts treated with different drugs. Doctors just want to know if pts take the drug or not. No confirmatory test was done.
Patient Sequence No: 1, Text Type: D, B5
[9347768]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2011-01775 |
| MDR Report Key | 2251575 |
| Report Source | 00,05 |
| Date Received | 2011-08-10 |
| Date of Report | 2011-08-10 |
| Date of Event | 2011-04-04 |
| Date Mfgr Received | 2011-07-11 |
| Date Added to Maude | 2011-10-20 |
| 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, MGR |
| 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 | DRUGS OF ABUSE TEST |
| Product Code | DJR |
| Date Received | 2011-08-10 |
| Model Number | 94400 |
| Lot Number | W48841B |
| 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 | 2011-08-10 |