MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-11-15 for RED -MLTI-DRG 6 PNL SCRN TST (DOA-164) manufactured by Alere San Diego, Inc..
[129189702]
Investigation conclusion: retention devices for the reported lot were tested with in-house drug free donor urine. All devices yielded expected negative results for all analytes at read time. No false positives 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. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[129189703]
The customer reported four occurrences of false positive coc, mamp, and opi results using the multi-drug 6 panel screen test on multiple donors. Confirmatory testing at a laboratory provided negative results. The false positive results occurred on four out of four devices used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00156 |
| MDR Report Key | 8075630 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-15 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-15 |
| 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 | RED -MLTI-DRG 6 PNL SCRN TST (DOA-164) |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2018-11-15 |
| Model Number | DOA-164 |
| Lot Number | DOA8020330 |
| 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 ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-15 |