MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PID; GRAM POSITIVE IDENTIFICATION PANEL

Model Number 448008

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

It was reported that the bd phoenix¿ pid misidentified staphylococcus capitis as leuconostoc lactis.The sample was retested on the maldi-tof, as well as another phoenix m50, with both returning the correct staphylococcus capitis result.There was no indication that results were reported to clinicians, and there was no report of patient impact.The following information was provided by the initial reporter: "wrong id result on phoenix m50 analyzer on pid panel.Result from phoenix m50 was leuconostoc lactis.The sample was sent an retested on maldi-tof and the correct result was staphylococcus capitis.The sample was tested also on another phoenix m50 with the pid panel from hospital.And the result was correct and it was staphylococcus capitis.Leuconostoc lactis is naturally resistant for vancomycin".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd phoenix¿ pid misidentified staphylococcus capitis as leuconostoc lactis.The sample was retested on the maldi-tof, as well as another phoenix m50, with both returning the correct staphylococcus capitis result.There was no indication that results were reported to clinicians, and there was no report of patient impact.The following information was provided by the initial reporter: "wrong id result on phoenix m50 analyzer on pid panel.Result from phoenix m50 was leuconostoc lactis.The sample was sent an retested on maldi-tof and the correct result was staphylococcus capitis.The sample was tested also on another phoenix m50 with the pid panel from hospital.And the result was correct and it was staphylococcus capitis.Leuconostoc lactis is naturally resistant for vancomycin".

Manufacturer Narrative

H.6 investigation summary: this complaint is for misidentification of staphylococcus capitis as leuconostoc lactis when using phoenix panel pid 448008 batch number 1033150.The complaint batch was not available for investigation due to the batch being expired at the time of the investigation and is beyond our stability timeframe.As a result, this complaint is unconfirmed for performance.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed three additional complaints on 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.Please continue to communicate any additional concerns.Per baltrmphxidastaph rev 10 version h, id 6.0-6.11, indicates the potential risk of a mis-identification was assessed as s4.H3 other text : see h.10.

• Brand Name: BD PHOENIX¿ PID
• Type of Device: GRAM POSITIVE IDENTIFICATION PANEL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13734117
• MDR Text Key: 287578648
• Report Number: 1119779-2022-00420
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 30382904480081
• UDI-Public: 30382904480081
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 448008
• Device Catalogue Number: 448008
• Device Lot Number: 1033150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1