MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-14 for MULTI-DRUG ONE STEP 9 DRUG SCREEN TEST PANEL (URINE) DOA-194-291-OBC12B manufactured by Alere San Diego, Inc..
[56001802]
Investigation conclusion: the customer's observation was not replicated in-house with retention devices. Retention devices were tested with in-house, drug-free urine. All bzo and coc results were negative at the 5 min read time and met qc specification. No false positive results were obtained. Manufacturing batch record review did not uncover any abnormalities. Root cause could not be determined based on the information provided.
Patient Sequence No: 1, Text Type: N, H10
[56001803]
Customer alleging they are receiving false positive results on the panel dip devices they have always ordered. They are using an unknown lab and the confirmation results were not available for this investigation. They are having false positive results for coc and bzo. They said this is happening on random different donors. Confirmation test: results not available. The control line is present, no test line. Number of tests: 625 tests, 25 failed. No additional or patient information provided. No adverse patient sequela reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2016-00636 |
| MDR Report Key | 5724799 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-14 |
| Date of Report | 2016-09-02 |
| Date Mfgr Received | 2016-09-02 |
| Date Added to Maude | 2016-06-14 |
| 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 | 0 |
| Brand Name | MULTI-DRUG ONE STEP 9 DRUG SCREEN TEST PANEL (URINE) |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | DKZ |
| Date Received | 2016-06-14 |
| Model Number | DOA-194-291-OBC12B |
| Lot Number | DOA6010106 |
| 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 | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-14 |