MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-13 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Alere San Diego, Inc..
[19207532]
Customer reported false negative acetaminophen (apap) for one pt tested on the urine tox screen test. Pt takes 750 mg of tylenol, chronically, three times per day. She was also taking vicodin. Three tests since april, the opi was always positive, but apap was always negative. Physician is questioning the result of tox. Other pt tests gave normal positive apap results.
Patient Sequence No: 1, Text Type: D, B5
[19446727]
Product support tested 3 replicates in qa retained w49252 devices with drug free urine, tox 1. 25x calibrator and r&d negative urine sample. Results as follows: no physical defects or error codes observed on devices. Time to results: within 15 minutes. Global statpak traces: elevated baseline observed on each in-house control tested. No discrepant results of false negative apap observed. Devices performed within mfg specification. Product support also tested 2 replicates of returned urine on qc retained w49252 devices. The returned urine was also tested on adulteration strips and sent out to nms labs for further hplc analysis. Results as follows: one returned urine labeled: (b)(6). No sample left after testing completed. Ph 10, specific gravity 1. 007 ug. Tox w49252, 2 reps tested: all positive for apap, opi, bzo. No other positive results observed. Time to results within 15 minutes. Triage tox threshold for apap: 5 ug/ml. No error codes reported and no physical defects observed on devices. Customer's negative apap results were not reproduced. Returned urine sample tested positive on tox w49252 and hplc detected 75 ug/ml apap which is above tox assay threshold of 5 ug/ml. Positive opi was due to vicodin medication. Positive bzo might also be due to medication. No corrective action required at this time as no product deficiency was established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2011-01531 |
| MDR Report Key | 2219997 |
| Report Source | 05 |
| Date Received | 2011-07-13 |
| Date of Report | 2011-07-13 |
| Date of Event | 2011-06-14 |
| Date Mfgr Received | 2011-06-21 |
| Date Added to Maude | 2011-10-24 |
| 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 | 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 |
| Removal Correction Number | NI |
| 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 | 2011-07-13 |
| Model Number | 94400 |
| Lot Number | W49252 |
| 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 | 2011-07-13 |