MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-15 for TRIAGE TOX DRUG SCREEN PANEL 94400 manufactured by Alere San Diego, Inc..
[57693174]
Investigation conclusion: investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[57693175]
Customer questioning 3 runs of tox panel on triage meter, each time run, different analytes tested positive. Customer stated a urine sample from one patient was tested 3 times on 2 triage meters and both meters gave the same results each time, but the results themselves were different for each run. The 1st run- 7 analytes tested positive. The 2nd run (time not provided)- just thc positive. The 3rd run (time not provided)- just thc and bar positive. Patient was visiting the hospital for a potential medication overdose. Customer was unable to recall patient data due to no patient identifier given on initial report. Caller unable to gather information on which specific analytes were positive on the first tests run. At the time reported, no confirmatory testing was performed. Although requested no confirmatory results were reported. No reported adverse patient sequela. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
[58752872]
Investigation/conclusion: received 1 false negative bar result when testing retain lot w61921 with positive tox calibrator 1. 5x. Review of the device scan showed an abnormally thin and long peak at the bar position, this is the root cause of the false negative result. No issues observed with tox calibrator 0. 5x testing. No sample was returned to product support, further investigation cannot be pursued. Reviewed the batch record for lot w61921. Lot met all final release specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2016-00650 |
| MDR Report Key | 6031967 |
| Date Received | 2016-10-15 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-08-24 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-10-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE TOX DRUG SCREEN PANEL |
| Generic Name | DOA DRUG SCREEN TEST |
| Product Code | DJR |
| Date Received | 2016-10-15 |
| Model Number | 94400 |
| Lot Number | W61921B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-15 |