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 2018-09-17 for MULTI-DRUG 3 PANEL SCREEN TEST DOA-234 manufactured by Alere San Diego, Inc..
[120528686]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[120528687]
The customer reported receiving false positive coc, mamp, and thc results on both staff and patients. The false positive results occurred on 75 devices out of 75 devices used. No confirmatory testing was performed and no adverse patient outcomes reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2018-00120 |
| MDR Report Key | 7883314 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-09-17 |
| Date of Report | 2018-09-17 |
| Date Mfgr Received | 2018-10-03 |
| Date Added to Maude | 2018-09-17 |
| 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 | MULTI-DRUG 3 PANEL SCREEN TEST |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2018-09-17 |
| Returned To Mfg | 2018-09-04 |
| Model Number | DOA-234 |
| Lot Number | DOA7040467 |
| Device Expiration Date | 2019-04-30 |
| 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 | 2018-09-17 |