MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-06 for LATERAL FLOW DRUG SCREEN 1-DUA-157-013 manufactured by Alere San Diego, Inc..
[4670192]
Caller alleging receiving discrepant correlation issue. Positive coc on single drug test vs negative coc on icup (i-dua-157-013). Single panel iscreen coc showed positive. Icup multidrug test showed negative for coc. Urine is fresh, 90-100 degrees. No confirmatory lab results provided.
Patient Sequence No: 1, Text Type: D, B5
[11911989]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2014-00551 |
| MDR Report Key | 3928494 |
| Report Source | 05 |
| Date Received | 2014-06-06 |
| Date of Report | 2014-05-13 |
| Date of Event | 2014-05-05 |
| Date Mfgr Received | 2014-05-13 |
| Date Added to Maude | 2014-07-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| 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 | LATERAL FLOW DRUG SCREEN |
| Generic Name | DRUGS OF ABUSE |
| Product Code | DKZ |
| Date Received | 2014-06-06 |
| Model Number | 1-DUA-157-013 |
| Lot Number | DOA-3110513 |
| 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 | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-06 |