Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 AND COMPANY, BD BIOSCIENCES BD CALIBRITE 3 BEADS; COUNTER, DIFFERENTIAL CELL
  • 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 AND COMPANY, BD BIOSCIENCES BD CALIBRITE 3 BEADS; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 340486
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that while using bd calibrite¿ 3 beads there was a failure for fl3.Patient impact was not reported.The following information was provided by the initial reporter, translated from spanish to english: in all cases we obtain failure result for fl3.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2020-00335 was sent in error.Patient sample was not used when running, therefore, this is not considered to be a reportable malfunction.
 
Event Description
It was reported that while using bd calibrite¿ 3 beads there was a failure for fl3.Patient impact was not reported.The following information was provided by the initial reporter, translated from spanish to english: in all cases we obtain failure result for fl3.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD CALIBRITE 3 BEADS
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
2350 qume drive
san jose CA 95131
MDR Report Key11098731
MDR Text Key225525976
Report Number2916837-2020-00335
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00382903404865
UDI-Public00382903404865
Combination Product (y/n)N
PMA/PMN Number
K973483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2021
Device Model Number340486
Device Catalogue Number340486
Device Lot Number9277450
Was Device Available for Evaluation? No
Date Manufacturer Received01/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-