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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PID; GRAM POSITIVE IDENTIFICATION PANEL
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BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PID; GRAM POSITIVE IDENTIFICATION PANEL Back to Search Results
Model Number 448008
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2022
Event Type  malfunction  
Event Description
It was reported that while testing with the bd phoenix¿ pid, discrepant results were obtained.A blood sample was identified as s.Epidermidis, but testing with maldi identified the same isolate as s.Hominis.Results were not 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 there were misidentifications.3 isolate was id¿d as s.Hominis by maldi, and s.Epidermidis by phoenix.
 
Manufacturer Narrative
Device evaluated by mfr: 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 while testing with the bd phoenix¿ pid, discrepant results were obtained.A blood sample was identified as s.Epidermidis, but testing with maldi identified the same isolate as s.Hominis.Results were not 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 there were misidentifications.3 isolate was id¿d as s.Hominis by maldi, and s.Epidermidis by phoenix.
 
Manufacturer Narrative
H.6 investigation summary this complaint is not confirmed.This complaint is for no id of s.Lugdunensis and mis id of s.Epidermidis as s.Captis and s.Hominis as s.Epidermidis when using phoenix panel pid (448008) batch number 1251467.The customer reports that the maldi identified the organisms as s.Lugdunensis, s.Epidermidis and s.Hominis respectively.The customer did not provide panel returns or isolates but did provide lab reports for the investigation.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, none of which have been confirmed.Bd id/ast plant quality will continue to monitor for trends and act 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 misidentification was assessed as s4.Per baltrmphxidastaph rev 10 version h, id 3.0-3.14, indicates the potential risk of no result (id or ast- using patient isolates) as an s3.
 
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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 Key13866180
MDR Text Key297240082
Report Number1119779-2022-00458
Device Sequence Number1
Product Code LQL
UDI-Device Identifier30382904480081
UDI-Public30382904480081
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2022
Device Model Number448008
Device Catalogue Number448008
Device Lot Number1251467
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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