BD PANEL PHOENIX NMIC-311
Report
- Report Number
- 1119779-2022-00664
- Event Type
- Malfunction
- Date Received
- May 7, 2022
- Date of Event
- February 16, 2022
- Report Date
- July 7, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- LON
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: 510K#:K032299. K061355. K061327. K031912. K023444. K063824. K033560. K063573. K041384. K060217. K052269. K190905. K032655. K062944. K060444. K173252. K033362. K062207. K063811. K163637. K151320. K063301. K031530. K060447. K032567. K060257. K023634. K123404. K020322. K132674. K173523. K063486. K022129. K023858. K071623 K031699. K060447. K024153. K060214. K132909. K042932.
THIS MDR WAS SUBMITTED TO CANCEL PREVIOUS MDRS. THE COMPLAINT IN QUESTION WAS REGARDING CAP SURVEYS WHICH DO NOT INVOLVE PATIENT SAMPLES. THIS COMPLAINT SHOULD BE CONSIDERED CANCELLED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE EXPIRATION DATE: 28FEB2023 H.4. DEVICE MANUFACTURE DATE:15FEB2022.
IT WAS REPORTED WHILE TESTING WITH BD PANEL PHOENIX NMIC-311 A FALSE SUSCEPTIBLE RESULT WAS REPORTED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER REPORTS CAP FAILURE WHEN USING NMIC-311 - 449252, LOT #2046646. PROTEUS MIRABILIS RESULT FAILURE WAS FOR AMPICILLIN, COMING IN AT LESS THAN OR EQUAL TO 4 - SENSITIVE - WHEN IT SHOULD HAVE RESULTED AS RESISTANT, ACCORDING TO CAP.. SEQUENCE NUMBER - 504521112445 CUSTOMER PROBLEM: CUSTOMER REPORTS CAP FAILURE WHEN USING NMIC-311 - 449252, LOT #2046646. PROTEUS MIRABILIS RESULT FAILURE WAS FOR AMPICILLIN, COMING IN AT LESS THAN OR EQUAL TO 4 - SENSITIVE - WHEN IT SHOULD HAVE RESULTED AS RESISTANT, ACCORDING TO CAP. FIRST RUN OF SAMPLE OCCURRED ON 2/16 PROTEUS MIRABILIS RESULTED AS =4 (SENSITIVE) WHEN IT SHOULD HAVE BEEN RESISTANT, AS PER CAP'S EXPECTATIONS. CUSTOMER HAS RUN THE ORGANISM ON THEIR M50 A TOTAL OF THREE TIMES AND RECEIVED THE SAME RESULT EACH TIME. THEY THEN REPEATED IT ON THEIR MICROSCAN ONCE - THE RESULT WAS RESISTANT. CUSTOMER REPORTS CAP FAILURE WHEN USING NMIC-311 - 449252, LOT #2046646. PROTEUS MIRABILIS RESULT FAILURE WAS FOR AMPICILLIN, COMING IN AT LESS THAN OR EQUAL TO 4 - SENSITIVE - WHEN IT SHOULD HAVE RESULTED AS RESISTANT, ACCORDING TO CAP.
IT WAS REPORTED WHILE TESTING WITH BD PANEL PHOENIX NMIC-311 A FALSE SUSCEPTIBLE RESULT WAS REPORTED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER REPORTS CAP FAILURE WHEN USING NMIC-311 - 449252, LOT #2046646. PROTEUS MIRABILIS RESULT FAILURE WAS FOR AMPICILLIN, COMING IN AT LESS THAN OR EQUAL TO 4 - SENSITIVE - WHEN IT SHOULD HAVE RESULTED AS RESISTANT, ACCORDING TO CAP.. 2/15 - SEQUENCE NUMBER - 504521117058. § CUSTOMER PROBLEM: CUSTOMER REPORTS CAP FAILURE WHEN USING NMIC-311 - 449252, LOT #2046646. PROTEUS MIRABILIS RESULT FAILURE WAS FOR AMPICILLIN, COMING IN AT LESS THAN OR EQUAL TO 4 - SENSITIVE - WHEN IT SHOULD HAVE RESULTED AS RESISTANT, ACCORDING TO CAP. FIRST RUN OF SAMPLE OCCURRED ON 2/15/22. PROTEUS MIRABILIS RESULTED AS =4 (SENSITIVE) WHEN IT SHOULD HAVE BEEN RESISTANT, AS PER CAP'S EXPECTATIONS. CUSTOMER HAS RUN THE ORGANISM ON THEIR M50 A TOTAL OF THREE TIMES AND RECEIVED THE SAME RESULT EACH TIME. THEY THEN REPEATED IT ON THEIR MICROSCAN ONCE - THE RESULT WAS RESISTANT. CUSTOMER REPORTS CAP FAILURE WHEN USING NMIC-311 - 449252, LOT #2046646. PROTEUS MIRABILIS RESULT FAILURE WAS FOR AMPICILLIN, COMING IN AT LESS THAN OR EQUAL TO 4 - SENSITIVE - WHEN IT SHOULD HAVE RESULTED AS RESISTANT, ACCORDING TO CAP.
IT WAS REPORTED WHILE TESTING WITH BD PANEL PHOENIX NMIC-311 A FALSE SUSCEPTIBLE RESULT WAS REPORTED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER REPORTS CAP FAILURE WHEN USING NMIC-311 - 449252, LOT #2046646. PROTEUS MIRABILIS RESULT FAILURE WAS FOR AMPICILLIN, COMING IN AT LESS THAN OR EQUAL TO 4 - SENSITIVE - WHEN IT SHOULD HAVE RESULTED AS RESISTANT, ACCORDING TO CAP.. 2/16 - SEQUENCE NUMBER - 504521112445 § CUSTOMER PROBLEM: CUSTOMER REPORTS CAP FAILURE WHEN USING NMIC-311 - 449252, LOT #2046646. PROTEUS MIRABILIS RESULT FAILURE WAS FOR AMPICILLIN, COMING IN AT LESS THAN OR EQUAL TO 4 - SENSITIVE - WHEN IT SHOULD HAVE RESULTED AS RESISTANT, ACCORDING TO CAP. FIRST RUN OF SAMPLE OCCURRED ON 2/16 PROTEUS MIRABILIS RESULTED AS =4 (SENSITIVE) WHEN IT SHOULD HAVE BEEN RESISTANT, AS PER CAP'S EXPECTATIONS. CUSTOMER HAS RUN THE ORGANISM ON THEIR M50 A TOTAL OF THREE TIMES AND RECEIVED THE SAME RESULT EACH TIME. THEY THEN REPEATED IT ON THEIR MICROSCAN ONCE - THE RESULT WAS RESISTANT. CUSTOMER REPORTS CAP FAILURE WHEN USING NMIC-311 - 449252, LOT #2046646. PROTEUS MIRABILIS RESULT FAILURE WAS FOR AMPICILLIN, COMING IN AT LESS THAN OR EQUAL TO 4 - SENSITIVE - WHEN IT SHOULD HAVE RESULTED AS RESISTANT, ACCORDING TO CAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1234485 | BD PANEL PHOENIX NMIC-311 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON, DICKINSON & CO. (SPARKS) | 1355006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |