FDA Adverse Event
Malfunction
Summary report: N
DRI METHADONE ASSAY
MDR report key: 21808950
·
Received April 9, 2025
Report
- Report Number
- 3010939897-2025-00001
- Event Type
- Malfunction
- Date Received
- April 9, 2025
- Report Date
- April 9, 2025
- Manufacturer
- MICROGENICS CORPORATION
- Product Code
- DJR
- PMA / PMN Number
- K023617
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT ID FOR THIS ISSUE IS (B)(4). MANUFACTURER AWARENESS DATE IS 14-MARCH-2025.
Description of Event or Problem · 0
FEMALE PATIENT ON METHADONE TREATMENT. RESULT WAS OBTAINED AT (B)(6) HOSPITAL IN. FEMALE PATIENT WAS IN A CRITICAL CONDITION AND REQUIRED IMMEDIATE TRANSFER TO ANOTHER FACILITY FOR SPECIALIZED CARE. PATIENT HAD NEGATIVE RESULT FOR DRI METHADONE ASSAY ON INDIKO PLUS ANALYZER PLATFORM. CONFIRMATORY TEST WAS POSITIVE. DATE OF EVENT IS UNKNOWN. IMPACT TO PATIENT MANAGEMENT UNKNOWN AT THIS TIME. AN EVALUATION IS IN PROCESS AND ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE AT THIS TIME. MANUFACTURER HAS CONTACTED CLINICAL LAB TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1420667 | DRI METHADONE ASSAY | Enzyme immunoassay, methadone | DJR | MICROGENICS CORPORATION | 1001640300884883012493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |