MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-01 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Alere San Diego, Inc..
[2063337]
Customer reported potential false negative results for opi and apap on urine tox screen test. Physician is suspecting false reading as pt is taking hydrocodone 20 mg/day, acetaminophen 2000 mg/day. Urine was clear without strange smell, and tested at room temperature. Earlier external qc showed normal results. Pt is taking actually one pill of vicodin (contains 1000 mg acetaminophen and 10 mg and hydrocodone) twice a day. She also takes soma (muscle relaxer, not sure of the dosage) and cymbalta 90 mg a day. The pt is out pt. No info on pt was available. Caller was not sure if pt had any symptoms or was suspected of overdose of acetaminophen. No serum drug test was ordered by doctor. Customer mentioned she was not sure if pt skipped the acetaminophen dosage, that might cause tox apap negative. No testing issues with other pts were observed.
Patient Sequence No: 1, Text Type: D, B5
[9216751]
Investigation: materials: qc retain tox. The 1. 25x tox cal (positive control), from mfg inventory: ln 233651. Triage meters with gsp and tmas. Customer complains of false negative apap and opi on tox w48898 with pt sample. Pt taking apap and opi medication. No sample was returned to alere for further testing. Ten reps 1. 25x tox cal were tested with w48898 devices. Results: no device issues or discrepant results observed. Time to results: within 15 minutes. No error codes reported. Global statpak device traces looked normal. Conclusions: customer did not return any sample for testing; product support was unable to verify the customer's complaint without in-house testing of pt sample. Device lot w48898 performed within mfg specifications. No corrective action required at this time as no product deficiency was established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2011-01457 |
| MDR Report Key | 2201031 |
| Report Source | 05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-07-01 |
| Date of Event | 2011-06-07 |
| Date Mfgr Received | 2011-06-07 |
| Date Added to Maude | 2011-09-23 |
| 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 | 3 |
| 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 | URINE DRUG SCREEN TEST |
| Product Code | DJR |
| Date Received | 2011-07-01 |
| Model Number | 94400 |
| Lot Number | W48898 |
| Device Expiration Date | 2011-10-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-07-01 |