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 2017-09-13 for ALERE ISCREEN 6 PANEL TEST DOA-264 manufactured by Alere San Diego, Inc..
[86116201]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[86116202]
The customer reported receiving false positive bzo and coc results using the alere iscreen 6 panel test. Laboratory testing produced negative results. Although requested, no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00144 |
| MDR Report Key | 6862631 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-09-13 |
| Date of Report | 2017-08-16 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-09-13 |
| 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 ISCREEN 6 PANEL TEST |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2017-09-13 |
| Returned To Mfg | 2017-09-14 |
| Model Number | DOA-264 |
| Lot Number | DOA6110466 |
| 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 | 2017-09-13 |