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 2017-05-08 for TRIAGE TOX DRUG SCREEN PANEL 94400EU manufactured by Alere San Diego, Inc..
[74756593]
Investigation conclusion: the customer's complaint of false negative coc was not replicated with in-house testing of retains of lot w62351rb. Manufacturing batch records for lot w62351rb 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
[74756594]
The customer reported the following event occurring on one patient: on (b)(6) 2017, the patient's urine sample was tested with the triage tox drug screen panel and produced a negative cocaine result. The triage tox drug screen panel cocaine threshold concentration is 300 ng/ml. An immunochromatography inlab cocaine test was performed and produced a positive result. The cut-off point for the inlab cocaine test is 300 ng/ml. The sample was sent to (b)(6) laboratory (kims methodology) and on (b)(6) 2017 a positive result cocaine was received. The cocaine decision level for the (b)(6) laboratory test is 150 ng/ml. Although requested, no additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00084 |
| MDR Report Key | 6553177 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-05-08 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-04-12 |
| Date Added to Maude | 2017-05-08 |
| 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 | 2017-05-08 |
| Model Number | 94400EU |
| Lot Number | W62351RB |
| 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 | 2017-05-08 |