MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD STEM CELL CONTROL KIT; COUNTER, DIFFERENTIAL CELL

Catalog Number UNKNOWN

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

Unknown manufacturer: (b)(4).Medical device expiration date: unknown.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 during use with an unspecified bd stem cell control kit there was erroneous absolute cd34-pe values on patient samples.There was no reported patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: (2 of 2 complaints) 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.Were the samples analyzed on the instrument patient samples? yes.If they were patient samples, were incorrect results obtained or used? no.Any treatment provide to the patient based on the result? no.Was there any harm to the patient? no.

Manufacturer Narrative

After further discussion with customer, it has been determined that the previously submitted mfr report# 2243072-2020-01613 was sent in error the stem cell control kit used was manufactured by another manufacturer, therefore, this would not be reportable for bd.

Event Description

It was reported that during use with an unspecified bd stem cell control kit there was erroneous absolute cd34-pe values on patient samples.There was no reported patient impact.The following information was provided by the initial reporter, translated from italian to english: (2 of 2 complaints).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.Were the samples analyzed on the instrument patient samples? yes.If they were patient samples, were incorrect results obtained or used? no.Any treatment provide to the patient based on the result? no.Was there any harm to the patient? no.

• Brand Name: UNSPECIFIED BD STEM CELL CONTROL KIT
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10657148
• MDR Text Key: 211917248
• Report Number: 2243072-2020-01613
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

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 Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other