MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2017-05-23 for TRIAGE TOX DRUG SCREEN PANEL 94400EU manufactured by Alere San Diego, Inc..
[75775955]
Investigation conclusion: the customer's complaint of false negative coc was not replicated with in-house testing of retains of lot w62468rb. Manufacturing batch records for lot w62468rb 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. This event is being reported as part number 94400eu is same/similar to k060791.
Patient Sequence No: 1, Text Type: N, H10
[75775956]
The customer reported continually receiving negative cocaine results using the triage tox drug screen panel. The customer performed confirmatory testing on one patient sample after receiving a negative cocaine result using the triage tox drug screen panel. The customer received a positive cocaine result of 389 ng/ml using the siemens dimension exl 200 analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00090 |
| MDR Report Key | 6585214 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2017-05-23 |
| Date of Report | 2017-04-24 |
| Date Mfgr Received | 2017-04-24 |
| Date Added to Maude | 2017-05-23 |
| 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 | 2017-05-23 |
| Model Number | 94400EU |
| Lot Number | W62468RB |
| 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 | 2017-05-23 |