MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-17 for MULTI-DRUG SCREEN CUP WITH DXLINK TECHNOLOGY DBD-187X manufactured by Alere San Diego, Inc..
[145392159]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[145392160]
It was reported that on an unspecified date, the patient presented for a drug screen. The reason for the drug screen is unknown. The patient's urine was tested on the multi drug screen cup with dxlink technology and received a presumptive positive result for coc. A verification test was performed on the dds urine system using the same sample immediately after and provided a negative result. There was no adverse outcome reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00088 |
| MDR Report Key | 8619321 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-17 |
| Date of Report | 2019-07-10 |
| Date Mfgr Received | 2019-07-01 |
| Date Added to Maude | 2019-05-17 |
| 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 | MULTI-DRUG SCREEN CUP WITH DXLINK TECHNOLOGY |
| Generic Name | DRUG SCREEN |
| Product Code | DIO |
| Date Received | 2019-05-17 |
| Model Number | DBD-187X |
| Lot Number | DOA8080491 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-05-17 |