MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. PKAPPA/CD23/CD19/CD5/CD38/45 CTT LYO CM

Catalog Number 624777

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2020

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 while using pkappa/cd23/cd19/cd5/cd38/45 ctt lyo cm there is no signal for kappa and cd23.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that there is no signal for kappa and cd23 in some lyotubes.What is the impacted 624777 batch/lot number? 0163232.When was this complaint batch first used by the lab? appears that there are intermittent pouches/bags that are affected and not entire batch.What is the 624774 batch number that was used as the control? do you have any data showing an alternate batch of 624777 that is performing differently from the complaint batch on the same sample? have you run an alternate 624777 batch as a control? -yes, will locate and send.Is patient data or diagnosis impacted in any way? yes to data ¿ not to diagnosis is the cd19 no signal repeatable across multiple pouches, instruments, technicians and samples? yes.

Manufacturer Narrative

The following fields have been updated with corrected information: b.5.Describe event or problem: it was reported while using pkappa/cd23/cd19/cd5/cd38/45 ctt lyo cm there is no signal for kappa and cd23.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that there is no signal for kappa and cd23 in some lyotubes.Additionally, on 202-01-08 the fse provided the following additional information: 1.What is the impacted 624777 batch/lot number? 0163232.2.When was this complaint batch first used by the lab? appears that there are intermittent pouches/bags that are affected and not entire batch.3.What is the 624774 batch number that was used as the control? 4.Do you have any data showing an alternate batch of 624777 that is performing differently from the complaint batch on the same sample? have you run an alternate 624777 batch as a control? -yes, will locate and send.5.Is patient data or diagnosis impacted in any way? yes to data, not to diagnosis 6.Is the cd19 no signal repeatable across multiple pouches, instruments, technicians and samples? yes.G.4.Date received by manufacturer: 2021-01-08.

Event Description

It was reported while using pkappa/cd23/cd19/cd5/cd38/45 ctt lyo cm there is no signal for kappa and cd23.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that there is no signal for kappa and cd23 in some lyotubes.Additionally, on 202-01-08 the fse provided the following additional information: 1.What is the impacted 624777 batch/lot number? 0163232.2.When was this complaint batch first used by the lab? appears that there are intermittent pouches/bags that are affected and not entire batch.3.What is the 624774 batch number that was used as the control? 4.Do you have any data showing an alternate batch of 624777 that is performing differently from the complaint batch on the same sample? have you run an alternate 624777 batch as a control? yes, will locate and send.5.Is patient data or diagnosis impacted in any way? yes to data, not to diagnosis 6.Is the cd19 no signal repeatable across multiple pouches, instruments, technicians and samples? yes.

• Brand Name: PKAPPA/CD23/CD19/CD5/CD38/45 CTT LYO CM
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; 10865 road to the cure; suite no. 210; san diego CA 92121
• MDR Report Key: 11207364
• MDR Text Key: 257361372
• Report Number: 3007886372-2021-00001
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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 Expiration Date: 01/31/2022
• Device Catalogue Number: 624777
• Device Lot Number: 0163232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1