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 2018-07-03 for ALERE TOX 9 PANEL INT ICUP DOA-197-251 manufactured by Alere San Diego, Inc..
[113508648]
Investigation conclusion: retention products for the reported lot were tested with in-house drug free donor urine and read at 5 minutes. All devices correctly yielded negative results for all coc150 strips. No false positives were observed. Manufacturing batch record review did not uncover any abnormalities. The presence of cross-reacting substances in the test sample may result in false positive results. See section "cross-reactivity" within the performance characteristics of the package insert for a list of the substances evaluated. Substances not listed have not been evaluated. For this reason, a secondary analytical 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
[113508649]
The customer reported receiving a false positive cocaine result using the alere toxicology icup 9 drug panel for one donor urine specimen as compared to a negative laboratory confirmatory result (lc/ms/ms cut-off=100 ng/ml). The customer reported that only one false positive cocaine result occurred out of 100 devices used. No treatment was provided or withheld based on the false positive result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00082 |
| MDR Report Key | 7659218 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-07-03 |
| Date of Report | 2018-07-03 |
| Date Mfgr Received | 2018-09-17 |
| Date Added to Maude | 2018-07-03 |
| 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 | ALERE TOX 9 PANEL INT ICUP DOA-197-251 |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2018-07-03 |
| Returned To Mfg | 2018-07-11 |
| Model Number | DOA-197 |
| Lot Number | DOA7040032 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-03 |