MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-16 for MULTI-DRUG 12 PANEL SCREEN (DOA-1124-081) manufactured by Alere San Diego, Inc..
[133939474]
Investigation conclusion: retention devices for the reported lot number were tested with in-house drug free urine. All results were read at 5 minutes and yielded expected negative results. No false positives for any of the analytes were observed. Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed. No relevant non-conformances, deviations, or abnormalities were found. All quality control specifications were met. Retention products performed as expected during in-house testing and could not replicate the reported complaint. This issue will be subject to tracking and trending. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results. Please refer to the "cross-reactivity" section within the performance characteristics portion of the package insert for a list of evaluated substances. This product provides only a qualitative, preliminary analytical result. A secondary method must be used to obtain a confirmed result.
Patient Sequence No: 1, Text Type: N, H10
[133939475]
On (b)(6) 2018: false positive coc and mamp 1x on the multi-drug 12 panel screen no further testing or lab testing was performed. Operator explained they think this donor should be negative and that this test was a false positive. Operator did not provide justification for why they think this donor should be negative. No treatment was provided or withheld based on the false positive results. No adverse outcomes reported. No alleged delay in treatment as a result of the false positive results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00006 |
| MDR Report Key | 8254948 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-16 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-12-26 |
| Date Mfgr Received | 2018-12-26 |
| Date Added to Maude | 2019-01-16 |
| 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 | 3 |
| 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 | MULTI-DRUG 12 PANEL SCREEN (DOA-1124-081) |
| Generic Name | DRUG SCREEN |
| Product Code | DIO |
| Date Received | 2019-01-16 |
| Model Number | DOA-1124 |
| Lot Number | DOA8060590 |
| 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 | 9975 SUMMERS RIDGE RD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-16 |