MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-12 for 8 PANEL INT CUP W/AD (DUE-187-071-08) manufactured by Alere San Diego, Inc..
[75169573]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[75169574]
The customer reported receiving false positive cocaine and thc results for five employees. The same employees were tested multiple times and positive cocaine and thc results were produced each time. Confirmatory testing was conducted and the laboratory testing produced negative cocaine and thc results.
Patient Sequence No: 1, Text Type: D, B5
[87061222]
Investigation conclusion: the customer's results were not replicated in-house with retention products of the reported lot. Retention products were tested with drug-free donor urine. All coc and thc strips produced negative results at the read time. False positive results were not observed during the investigation. Manufacturing batch record review did not uncover any abnormalities. 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
| Report Number | 2027969-2017-00086 |
| MDR Report Key | 6564852 |
| Report Source | CONSUMER |
| Date Received | 2017-05-12 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2017-05-12 |
| 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 | 8 PANEL INT CUP W/AD (DUE-187-071-08) |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2017-05-12 |
| Returned To Mfg | 2017-08-31 |
| Model Number | DUE-187 |
| Lot Number | DOA6020488 |
| 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 | 2017-05-12 |