MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-22 for TRIAGE TOX DRUG SCREEN WITH MTD 94400 manufactured by Biosite Incorporated.
[1133815]
Caller alleged false negative acetaminophen (apap) when testing triage tox screen with another format. Caller was performing correlation with another facility. One sample was negative for apap at their facility with dln w44049; a sample was frozen and sent to the other lab and got a positive apap result with w44683. After this result, caller went back to original frozen sample and retested in her lab on dln w44063 and got positive apap. Positive control ran fine on original lot. No pt reports of invasive procedures or injury.
Patient Sequence No: 1, Text Type: D, B5
[8382013]
Investigation is pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2009-00466 |
| MDR Report Key | 1474823 |
| Report Source | 05 |
| Date Received | 2009-06-22 |
| Date of Report | 2009-06-22 |
| Date of Event | 2009-05-26 |
| Date Mfgr Received | 2009-05-26 |
| Date Added to Maude | 2009-10-26 |
| 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, MANAGER |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE TOX DRUG SCREEN WITH MTD |
| Generic Name | DRUG SCREEN TEST |
| Product Code | MVO |
| Date Received | 2009-06-22 |
| Model Number | 94400 |
| Lot Number | W44049 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSITE INCORPORATED |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-22 |