MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES BD STEM CELL CONTROL KIT 15 TESTS IVD; COUNTER, DIFFERENTIAL CELL

Catalog Number	340991
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after using bd stem cell control kit 15 tests ivd erroneous results were acquired.The following information was provided by the initial reporter: abnormally high blood cell count.A new lot of 340991 was measured and was far off the median value on the spec sheet and did not enter the reference value.We tried multiple times with different measurers and equipment, but the value remained high.1.Are there erroneous results on patient samples from diagnostic test? yes 2.Was there any delay of treatment due to the issue? no 3.If patient samples were redrawn, was there any change or delay of treatment? no 4.Was there any physical harm/injury to the patient due to the issue? no.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that after using bd stem cell control kit 15 tests ivd erroneous results were acquired.The following information was provided by the initial reporter: abnormally high blood cell count.A new lot of 340991 was measured and was far off the median value on the spec sheet and did not enter the reference value.We tried multiple times with different measurers and equipment, but the value remained high.1.Are there erroneous results on patient samples from diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.3.If patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue? no.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information: reporting office: becton dickinson and company bd biosciences.Reporting office contact: (b)(6) - mdr.Manufacturing site contact: (b)(6) - mdr.Based on the investigation results, the reported issue of high cell counts was confirmed.Investigation results that were obtained regarding the indicated failure mode were the following: user data were returned including results of analysis showing customer calculations.Documentation for part lot 340991-bc1123 was reviewed and met specifications prior to release.The supplier investigation discovered customer miscalculation that accounted for results above expected values.Based on the investigation results, the reported issue of high cell counts was confirmed.The issue was resolved by providing customer with a replacement lot.The replacement lot resolved the reported issue of the customer complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that after using bd stem cell control kit 15 tests ivd erroneous results were acquired.The following information was provided by the initial reporter: abnormally high blood cell count.A new lot of 340991 was measured and was far off the median value on the spec sheet and did not enter the reference value.We tried multiple times with different measurers and equipment, but the value remained high.1.Are there erroneous results on patient samples from diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.3.If patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue? no.
Additional Manufacturer Narrative
Investigation summary has been corrected.H.6 investigation summary: based on the investigation results, the reported issue of high cell counts was confirmed.Investigation results that were obtained regarding the indicated failure mode were the following: ¿ user data were returned including results of analysis showing customer calculations.¿ documentation for part lot 340991-bc1123 was reviewed and met specifications prior to release.¿ the supplier investigation discovered customer decisions that accounted for results above expected values.The elevated number of cd34+ cells can be attributed by the gating of cd45+ lymphocytes.It¿s recommended to use appropriate gating in which cd45 bright nonspecific events are removed.¿ the replacement lot resolved the reported issue of the customer.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD STEM CELL CONTROL KIT 15 TESTS IVD
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18321006
• Report Number: 2916837-2023-00228
• Device Sequence Number: 7437864
• Product Code: GGL
• UDI-Device Identifier: 00382903409914
• UDI-Public: (01)00382903409914
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2024

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
• Operator of Device: Other
• Device Expiration Date: 12/02/2023
• Device Catalogue Number: 340991
• Device Lot Number: BC1123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 03/28/2024; 06/20/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 03/29/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown