• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BECTON DICKINSON STREP A ANTIGEN DETECTION

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON BECTON DICKINSON STREP A ANTIGEN DETECTION Back to Search Results
Model Number BD CHECK GROUP A STREP
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2017
Event Type  malfunction  
Event Description
Performing a proficiency testing mle m1 specimen rs-1 for streptococcus a. We had a negative result upon completion of the test. When we received our proficiency testing back from mle, they report that the result should have been positive. Was someone operating the medical device when the problem occurred: yes. If yes, who was using it: a health professional.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBECTON DICKINSON STREP A ANTIGEN DETECTION
Type of DeviceBECTON DICKINSON STREP A ANTIGEN DETECTION
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key6900165
MDR Text Key87843493
Report NumberMW5072515
Device Sequence Number0
Product Code GTY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2017
Device Model NumberBD CHECK GROUP A STREP
Device Lot Number#STA5110004
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-