MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-11 for TRIAGE DOA 25 TEST 92590 manufactured by Alere San Diego, Inc..
[65038893]
Investigation conclusion: investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[65038894]
Report received of conflicting results provided by triage doa 25 test. Event occurred in (b)(6). Customer alleges a conflicting result has already been seen in more than one case and the issue was observed not at a specific analyte (i. E. , depending on cases, conflicting results have been seen in different analytes). This customer's institute is a hospital particularly focusing on clinical trials and has been using this product for a long time. When using this particular lot (#382197), the customer has been witnessing inconsistent width of lines (narrow / wide lines), as well as conflicting test results (positive and negative) for identical samples. No reported adverse patient sequela. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[65930842]
Investigation/conclusion: a review was completed of the batch record for lot 382197. Lot met all final release specifications. In-house testing of 29 drug free urine donors on the complaint lot 382197 did not replicate the complaint. All devices tested provided expected negative results. No product deficiency was established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2017-00014 |
| MDR Report Key | 6244283 |
| Date Received | 2017-01-11 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2017-01-16 |
| Date Added to Maude | 2017-01-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | TRIAGE DOA 25 TEST |
| Generic Name | DRUG OF ABUSE TEST |
| Product Code | MGX |
| Date Received | 2017-01-11 |
| Model Number | 92590 |
| Lot Number | 382197 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-01-11 |