FDA Adverse Event
Malfunction
Summary report: N
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
MDR report key: 23831725
·
Received December 17, 2025
Report
- Report Number
- 1119779-2025-05516
- Event Type
- Malfunction
- Date Received
- December 17, 2025
- Date of Event
- October 13, 2025
- Report Date
- December 17, 2025
- 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
- MN, US
- 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 THAT DURING USE OF BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, A FALSE POSITIVE GIARDIA PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2186579 | 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 |