FDA Adverse Event
Malfunction
Summary report: N
CHROMID TM MRSA SMART AGAR
MDR report key: 5298100
·
Received December 15, 2015
Report
- Report Number
- 3002769706-2015-00172
- Event Type
- Malfunction
- Date Received
- December 15, 2015
- Report Date
- November 24, 2015
- Manufacturer
- BIOMÉRIEUX SA
- Product Code
- JSO
- PMA / PMN Number
- K091024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A FALSE POSITIVE RESULT IN ASSOCIATION WITH (B)(6). A STENOTROPHOMONAS MALTOPHILIA ORGANISM PRESENTED AS (B)(6). THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS WERE REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 827648 | CHROMID TM MRSA SMART AGAR | CHROMID MRSA SMART AGAR | JSO | BIOMÉRIEUX SA | 1004280240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |