MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2011-02-15 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Alere San Diego, Inc..
[16090193]
Samples may have contained metabolite levels near the cut off level for each drug class. No sample was returned for testing; product support was unable to verify the customer's result. Product support could not rule out any sample specific or environmental factor that may have affected analyte recovery. This issue will be tracked and trended to detect any further occurrence. An investigation of each lot number involved in this case indicates that the number of calls does not exceed historic levels of call volume per lot for the product(s) involved. Root cause analysis will not be requested at this time. Info related to this call is captured and is available if root cause analysis is required in the future. All complaints are subject to routine tracking and trending. Corrective action not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[16324415]
Caller reported false negative acetaminophen results using the triage tox drug screen meter: results as follows: pt's urine sample was run on the triage meter three times and all test results were negative for (b)(6). Pt sample was then analyzed using gc/ms and came back positive for (b)(6). No urine analysis was performed. Sample was clear and not centrifuged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2011-00317 |
| MDR Report Key | 2022514 |
| Report Source | 00,05 |
| Date Received | 2011-02-15 |
| Date of Report | 2011-02-15 |
| Date of Event | 2010-12-09 |
| Date Mfgr Received | 2010-12-09 |
| Date Added to Maude | 2011-03-31 |
| 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 | CARMEN BERGELIN, MGR. |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE TOX DRUG SCREEN WITH MTD |
| Generic Name | DRUGS OF ABUSE TEST |
| Product Code | DJR |
| Date Received | 2011-02-15 |
| Model Number | 94400 |
| Lot Number | W48469 |
| ID Number | SERIAL #45471 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2011-02-15 |