FDA Adverse Event Malfunction Summary report: N

PANEL PHOENIX PMIC-110

MDR report key: 24716093 · Received March 30, 2026

Report

Report Number: 1119779-2026-00585
Event Type: Malfunction
Date Received: March 30, 2026
Date of Event: February 27, 2026
Report Date: March 23, 2026
Manufacturer: BECTON DICKINSON & CO. (SPARKS)
Product Code: LON
UDI-DI: 30382904490363
PMA / PMN Number: SEE H11
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020322, K021954, K022172, K023273, K023301, K023568, K024152, K030091, K030677, K031306, K031679, K032131, K033784, K033889, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, K082913, K131331, AND K14046. H3. 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 PANEL PHOENIX PMIC-110 A PATIENT ISOLATE (ENTEROCOCCUS FAECALIS) HAD AN INTERMEDIATE MIC (FALSE RESISTANT) FOR THE DRUG DAPTOMYCIN. THE USER PERFORMED REPEAT TESTING, STATING SOME RESULTS WERE ACCURATE AFTER REPEAT WHILE OTHERS WERE NOT. THE USER ALSO STATED THAT THEY DO NOT REPORT RESULTS THEY DO NOT TRUST TO PROVIDERS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
776915	PANEL PHOENIX PMIC-110	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION	LON	BECTON DICKINSON & CO. (SPARKS)		5301898	30382904490363

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown