FDA Adverse Event
Malfunction
Summary report: N
TRIAGE TOX DRUG SCREEN WITH MTD
MDR report key: 1474823
·
Received June 22, 2009
Report
- Report Number
- 2027969-2009-00466
- Event Type
- Malfunction
- Date Received
- June 22, 2009
- Date of Event
- May 26, 2009
- Report Date
- June 22, 2009
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- MVO
- PMA / PMN Number
- 030286
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS PENDING.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE TOX DRUG SCREEN WITH MTD | DRUG SCREEN TEST | MVO | BIOSITE INCORPORATED | 94400 | W44049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |