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 UNKNOWN BRAND NAME manufactured by Alere San Diego, Inc..
[70770124]
Investigation conclusion: further investigation to determine whether the product failed to meet specifications cannot be pursued because the customer provided an invalid lot number. This complaint was identified during an assessment of customer interaction records as part of capa-(b)(4). The available information is limited and no additional information is able to be obtained. The lot number of the device provided by the customer has been confirmed to be an invalid lot number. A valid lot number could not be obtained. No additional information regarding the product identity was provided. Therefore the brand name, model number and the 510k number could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[70770125]
The customer reported receiving a false positive thc result and a false positive cocaine result. No additional information was provided
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2017-00050 |
| MDR Report Key | 6430693 |
| Report Source | CONSUMER |
| Date Received | 2017-03-24 |
| Date of Report | 2013-09-10 |
| Date Mfgr Received | 2013-09-10 |
| 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 | UNKNOWN BRAND NAME |
| Generic Name | ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES |
| Product Code | DIO |
| Date Received | 2017-03-24 |
| Model Number | UNKNOWN |
| Lot Number | DOA3050367 |
| 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 |