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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES HPS CUSTOMER BB790-P CUSTOM
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES HPS CUSTOMER BB790-P CUSTOM Back to Search Results
Catalog Number 625315
Device Problem Low Readings (2460)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown initial reporter phone#: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown (b)(4).
 
Event Description
It was reported that while using reagent hps customer bb790-p custom the cd14 antibody in bb790 did not work on customers cells, while fluorochrome fitc and v450 does on the same sample.There was no report of patient impact.
 
Manufacturer Narrative
H6: investigation summary: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2020-00321 was sent in error.The erroneous result that occurred was not on a patient sample it was a control sample and therefore, not considered to be a reportable malfunction.
 
Event Description
It was reported that while using reagent hps customer bb790-p custom the cd14 antibody in bb790 did not work on customers cells, while fluorochrome fitc and v450 does on the same sample.There was no report of patient impact.
 
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Brand Name
HPS CUSTOMER BB790-P CUSTOM
Type of Device
NA
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
2350 qume drive
san jose CA 95131
MDR Report Key11060449
MDR Text Key224154880
Report Number2916837-2020-00321
Device Sequence Number1
Product Code MVU
Combination Product (y/n)N
PMA/PMN Number
NA
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 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number625315
Device Lot Number624296
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/27/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received02/22/2021
Supplement Dates FDA Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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