MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2014-08-13 for MULTI DRUG ONE STEP SCREEN TEST PANEL (URINE) DOA 174 - 691 manufactured by Alere San Diego, Inc..
[4731660]
Customer reported potential false negative cocaine results with the multi drug one step screen test panel (urine) test. When the sample was tested at the lab, the result was positive. A company had employees in for site access testing and the company wanted the 7 panel point of care test (multi drug one step screen test panel - urine) used as well as having samples sent to the lab. While doing the testing, all the specific gravity and ph readings were within the normal range and they were negative for oxidants. Each test had all of the lines show up indicating negative results. Samples were sent to the lab and a sample from one of the employees came back as positive for cocaine. No samples are available. Laboratory report requested but is not available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2014-00752 |
| MDR Report Key | 4066610 |
| Report Source | 01,07,08 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-07-18 |
| Date of Event | 2014-07-18 |
| Date Mfgr Received | 2014-07-18 |
| Date Added to Maude | 2014-09-11 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI DRUG ONE STEP SCREEN TEST PANEL (URINE) |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | DKZ |
| Date Received | 2014-08-13 |
| Model Number | DOA 174 - 691 |
| Lot Number | DOA2100409 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-08-13 |