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 2017-03-27 for TRIAGE TOX DRUG SCREEN PANEL 94400EU manufactured by Alere San Diego, Inc..
[70999984]
Investigation conclusion: the customer's complaint of a false positive cocaine was not replicated with in-house testing of retains of lot w62368. Manufacturing batch records for lot w62368 were reviewed and found that the lot met release specifications. 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
[70999985]
The customer reported a false positive cocaine results on a (b)(6) infant. The mother was reported as taking subutex which contains buprenorphine. No confirmatory testing was conducted. This event is being reported as the device is same/similar to k060791.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00053 |
| MDR Report Key | 6437326 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-03-27 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-02-28 |
| Date Mfgr Received | 2017-03-01 |
| Date Added to Maude | 2017-03-27 |
| 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 | TRIAGE TOX DRUG SCREEN PANEL |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2017-03-27 |
| Model Number | 94400EU |
| Lot Number | W62368RB |
| 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 | 2017-03-27 |