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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 12/08/2021
Event Type  malfunction  
Event Description
It was reported that while using 25 bd phoenix¿ pid misidentification was observed by the laboratory personnel.The sample was sent to an external lab to confirm the results.The customer stated that results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "wrong final identification on phoenix m50 analyzer (pid panels).Result from phoenix m50-staphylococcus epidermidis.The proper result should be staphylococcus aureus.Sample was sent to external lab for confirmatory testing and the result was staphylococcus aureus.".
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that while using 25 bd phoenix¿ pid misidentification was observed by the laboratory personnel.The sample was sent to an external lab to confirm the results.The customer stated that results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "wrong final identification on phoenix m50 analyzer (pid panels).Result from phoenix m50-staphylococcus epidermidis.The proper result should be staphylococcus aureus.Sample was sent to external lab for confirmatory testing and the result was staphylococcus aureus.".
 
Manufacturer Narrative
H.6.Investigation summary: "this complaint is for misidentification of staphylococcus aureus as staphylococcus epidermidis when using phoenix panel pid (448008) batch number 1033150.The customer did not return lab reports, isolates or panels for investigation.To investigate, a total of four retention panels from the same catalog number but different batch as the complaint batch using four different in house isolates of staphylococcus aureus ((b)(4)).One panel was tested per isolate on a phoenix instrument and evaluated for identification results.Two panels identified correctly as staphylococcus aureus ((b)(4)).The other two panels identified incorrectly as staphylococcus epidermidis ((b)(4)).This complaint is confirmed for misidentification.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed two 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.".
 
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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 Key13194103
MDR Text Key289439807
Report Number1119779-2021-02100
Device Sequence Number1
Product Code LQL
UDI-Device Identifier30382904480081
UDI-Public30382904480081
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 07/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2022
Device Model Number448008
Device Catalogue Number448008
Device Lot Number1033150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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