FDA Adverse Event
Malfunction
Summary report: N
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
MDR report key: 25217976
·
Received May 19, 2026
Report
- Report Number
- 1119779-2026-00797
- Event Type
- Malfunction
- Date Received
- May 19, 2026
- Date of Event
- April 28, 2026
- Report Date
- May 7, 2026
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- OOI
- UDI-DI
- 00382904419165
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D.2. ADDITIONAL MEDICAL DEVICE TYPES: NQX, NJR, OZN. G.4. THERE WERE MULTIPLE PMA/510K NUMBERS: K111860, K120138, K130470. 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 THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, A SAMPLE THAT HAD PREVIOUSLY GIVEN A POSITIVE RESULT GAVE A NEGATIVE RESULT UPON REPEAT TESTING. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 616862 | BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT | THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY | OOI | BECTON, DICKINSON & CO. (SPARKS) | 00382904419165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |