MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCAN SYSTEM GERMAN WITH DDM

Catalog Number 34001080

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.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 during use with a bd facscan system german with ddm there were erroneous absolute values on patient samples.No erroneous results were released and there was no reported patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: the customer reports that for a few days the absolute cd34-pe values have been lower than the acceptable range of the bd stem cell controls kit.Additional information received from the customer: "the instrument is used to analyze peripheral and apheretic blood samples from patients who are candidates for autologous transplantation.To our knowledge we have no wrong data.The data of the cd34 cells provided by us is used to determine when to start the apheretic collection procedure and when to stop it.There has never been any harm to patients".Comments: probable deterioration of one of the reference samples.General control of the instrument, no problems of alignment, new preparation and analysis of the samples.From the results there does not appear to be an instrumental problem.The customer reserves the right to carry out other tests.

Manufacturer Narrative

After further discussion with the customer, it has been determined that the previously submitted mfr report# 2916837-2020-00156 was sent in error.The instrument is not the source of the error the issue was with a stem control kit not manufactured by bd.

Event Description

It was reported that during use with a bd facscan system german with ddm there were erroneous absolute values on patient samples.No erroneous results were released and there was no reported patient impact.The following information was provided by the initial reporter, translated from italian to english: the customer reports that for a few days the absolute cd34-pe values have been lower than the acceptable range of the bd stem cell controls kit.Additional information received from the customer: " the instrument is used to analyze peripheral and apheretic blood samples from patients who are candidates for autologous transplantation.To our knowledge we have no wrong data.The data of the cd34 cells provided by us is used to determine when to start the apheretic collection procedure and when to stop it.There has never been any harm to patients." comments: probable deterioration of one of the reference samples.General control of the instrument, no problems of alignment, new preparation and analysis of the samples.From the results there does not appear to be an instrumental problem.The customer reserves the right to carry out other tests.

• Brand Name: BD FACSCAN SYSTEM GERMAN WITH DDM
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10638434
• MDR Text Key: 238137045
• Report Number: 2916837-2020-00156
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 34001080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other