MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-24 for CONSTRUCTION 12-DRG TST CARD (DOA-1124T) 4580330099 manufactured by Alere San Diego, Inc..
[70810300]
Investigation conclusion: this lot has not been previously tested. Because the lot is expired and no longer available, further investigation is not possible. This complaint was identified during an assessment of customer interaction records as part of (b)(4). The available information is limited and no additional information is able to be obtained.
Patient Sequence No: 1, Text Type: N, H10
[70810301]
The customer reported receiving a false positive result on the device. The customer confirmed the false result at the lab but did not confirm with gc/ms. The customer performed a secondary screen with panel 934. No additional information was provided..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00052 |
| MDR Report Key | 6430689 |
| Report Source | CONSUMER |
| Date Received | 2017-03-24 |
| Date of Report | 2014-10-20 |
| Date Mfgr Received | 2014-10-20 |
| Date Added to Maude | 2017-03-24 |
| 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 | CONSTRUCTION 12-DRG TST CARD (DOA-1124T) |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2017-03-24 |
| Model Number | 4580330099 |
| Lot Number | DOA4060151 |
| 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 | 2017-03-24 |