MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-28 for TRIAGE TOX DRUG SCREEN W/MTD 94400 manufactured by Alere San Diego Inc.
[4587801]
Customer reported false positive apap results when testing one pt urine sample with their new lot of product against a previous lot. The current lot gave consistent positive apap results and the previous lot gave consistent negative apap results on tow consecutive runs side by side. Previously this sample was labeled as +opi, +thc which was reproduced on all of the tests on both lots. Diagnostics and medication for this pt are not available at this time. The external controls ran normal results with both negative and positive. Technical service rep follow up with the customer who indicated the sample was used as a 'standard' to test for lot to lot variability. No pt info is available.
Patient Sequence No: 1, Text Type: D, B5
[12031775]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2014-00505 |
| MDR Report Key | 3921946 |
| Report Source | 05 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-08 |
| Date of Event | 2014-05-08 |
| Date Added to Maude | 2014-07-21 |
| 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 | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| 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 W/MTD |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | DJR |
| Date Received | 2014-05-28 |
| Model Number | 94400 |
| Lot Number | W56669B |
| 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 | 2014-05-28 |