FDA Adverse Event
Malfunction
Summary report: N
BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTION
MDR report key: 24877565
·
Received April 14, 2026
Report
- Report Number
- 3010141591-2026-00003
- Event Type
- Malfunction
- Date Received
- April 14, 2026
- Date of Event
- March 16, 2026
- Report Date
- April 15, 2026
- Manufacturer
- BD KIESTRA LAB AUTOMATION
- Product Code
- KZB
- UDI-DI
- 00382904449025
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED WHILE USING BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTION, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 938472 | BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTION | CALCULATOR/DATA PROCESSING MODULE | KZB | BD KIESTRA LAB AUTOMATION | 00382904449025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |