MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX PMIC/ID-106; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number 448606

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Pma / 510k number: the bd phoenix pmic/id-106 is an antimicrobial resistance panel which consists of a combination of the following 510k numbers: k131331, k020322, k021954, k022172, k023273, k023301, k024152, k030677, k031306, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k082538, k082852, k082913.

Event Description

It was reported that while using bd phoenix¿ pmic/id-106 a misidentification was observed by the laboratory personnel.A gram stain test and a reference lab test were used to confirm the results as a misidentification.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: " organism was id'd as corynebacterium striatum, by (b)(6) , at a reference lab.It was reported that an isolate that the gram stain was a gram positive rod.Customer problem: misidentification.Steps taken with customer/troubleshooting: customer had an isolate that the gram stain was a gram positive rod.Isolate was identified by the m50 as strep.Oralis twice.Isolate return expected.".

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2021-05-20 investigation summary: this complaint is for misidentification of corynebacterium striatum as streptococcus oralis when using phoenix panel pmic/id-106 (448606) batch number 0342590.The customer did return isolates, lab reports, and panels for investigation.To investigate, a total of three (3) customer returned panels from the complaint batch were tested using customer returned isolates of corynebacterium striatum on a phoenix m50 instrument and evaluated for identification results.During investigation, all three (3) panels tested identified incorrectly.Two (2) panels identified as staphylococcus schleiferi and one (1) panel identified as streptococcus oralis.Since all panels yielded unsatisfactory identification results, this complaint is confirmed.It is to be noted that maldi testing was also performed on the customer returned isolates and yielded an identification of corynebacterium striatum.A review of quality notifications revealed no quality notifications for the complaint batch.A review of complaints revealed one (1) additional complaint for the complaint batch.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.

Event Description

It was reported that while using bd phoenix¿ pmic/id-106 a misidentification was observed by the laboratory personnel.A gram stain test and a reference lab test were used to confirm the results as a misidentification.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: "organism was id'd as corynebacterium striatum, by maldi, at a reference lab.It was reported that an isolate that the gram stain was a gram positive rod.Customer problem: misidentification.Steps taken with customer/troubleshooting: customer had an isolate that the gram stain was a gram positive rod.Isolate was identified by the m50 as strep.Oralis twice.Isolate return expected.".

• Brand Name: BD PHOENIX PMIC/ID-106
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11754350
• MDR Text Key: 277774720
• Report Number: 1119779-2021-00750
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382904486069
• UDI-Public: 30382904486069
• Combination Product (y/n): N
• PMA/PMN Number: K021954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 448606
• Device Catalogue Number: 448606
• Device Lot Number: 0342590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1