FDA Adverse Event
Malfunction
Summary report: N
ORTHO SERA ANTI-FYB
MDR report key: 18189734
·
Received November 22, 2023
Report
- Report Number
- 3011683976-2023-00015
- Event Type
- Malfunction
- Date Received
- November 22, 2023
- Date of Event
- October 27, 2023
- Report Date
- September 30, 2024
- Manufacturer
- ALBA BIOSCIENCE LIMITED (LTD.)
- Product Code
- QHT
- PMA / PMN Number
- 125342
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
FOLLOW UP 01 OF 3011683976-2023-00015.
Additional Manufacturer Narrative · 0
H3 - OTHER - INVESTIGATION PERFORMED ON RETAINED SAMPLE FROM THE SAME BATCH. INTERNAL INVESTIGATION CONSISTED OF BOTH BATCH MANUFACTURING RECORD (BMR) REVIEWS AND INVESTIGATIVE TESTING. OUR INVESTIGATION HAS CONFIRMED THAT ORTHO¿ SERA ANTI-FYB PRODUCT FD153M LOT V254104 TO BE FIT FOR PURPOSE THEREFORE THIS COMPLAINT IS NOT CONFIRMED ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).
Description of Event or Problem · 0
CUSTOMER HAS REPORTED A FALSE POSITIVE FOR ORTHO SERA ANTI-FYB, PRODUCT FD153M LOT V254104, EXPIRY 28-DEC-24 IN COMBINATION WITH MULTIPLE LOTS OF MTS ANTI-IGG GEL CARDS WHEN TESTING ONE PATIENT SAMPLE AND THREE DONOR SAMPLES ON THEIR ORTHO VISION ANALYZERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 917739 | ORTHO SERA ANTI-FYB | REAGENT RED BLOOD CELLS | QHT | ALBA BIOSCIENCE LIMITED (LTD.) | FD153M | V254104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |