MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD LEUCOCOUNT; COUNTER, DIFFERENTIAL CELL

Model Number	340523
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	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while testing patient samples with bd leucocount¿ there were unexpected results.There was no report of confirmatory testing or patient impact.The following information was provided by the initial reporter: the customer encountered two unexpected results (sample id: (b)(6) and (b)(6)) as well as the iqc (lkr0521h).Staining protocol: 400 l of bd leucocount reagent [lot 0294545 expiry date 31/03/22] + 100l of our sample in a bd trucount tube [lot n°20276, 48 600 beads, expiry date 31/10/22].
Additional Manufacturer Narrative
H6: investigation summary scope the scope of issue is limited to part 340523 and lot 0329583.Manufacturing defect trend: there are no qns for manufacturing non-conformances related to the reported issue for the date range from 25jun2020 to 25jun2021.Complaint trend: there were no other complaints related to the reported issue in addition to this complaint for the date range from 25jun2020 to 25jun2021.Batch history record (bhr) review: bhr part lot was reviewed for part 340523, lot 0329583 and is attached.Bhr part lot for reagent component part 340502, lot 0294545 was reviewed and no non-conformances were reported; these materials met all manufacturing specifications prior to release.Retain sample evaluation / testing: retain sample was not tested; consultation on the user data produced a consensus that some form of debris/contamination resulted in extreme intrusion of unintended stain components into the cytometric output.Returned sample evaluation: the sample was not requested to be returned.This is the only performance complaint reported for part 340523, lot 0329583, out of 2,018 units produced.Investigation result / analysis: user data show unexpected amounts of debris.Threshold is likely set too low; the source of debris containing nucleic acid should be explored.User is acquiring ~20% of the tube.Advice is to run their wash/run buffer in a normal tube prep a sample tube without reagent.This is the only performance complaint reported for part 340523, lot 0329583, out of 2,018 units produced.The investigation was performed: based on the review of user data, complaint trend, defect trend, bhr, root cause and risk analysis, the reported complaint was unconfirmed.¿risk analysis: risk review: leucocount risk management file rmf340523, revision a, was reviewed.Hazard(s) identified? yes.If no (to above), what actions will be taken? hazard:_wrong answer_____ cause:_various_____ harmful effects:_leucocytes miscounted_____.Severity: __=3____.Probability: __=5___.Ri: __=iv____.Risk control: _various_____.New hazard: _no__.Mitigation(s) sufficient yes; root cause analysis: based on the investigation result, root cause was not determined.Investigation conclusion: based on the investigation result, complaint was not confirmed.
Event or Problem Description
It was reported that while testing patient samples with bd leucocount¿ there were unexpected results.There was no report of confirmatory testing or patient impact.The following information was provided by the initial reporter: the customer encountered two unexpected results (sample id: (b)(6)) as well as the iqc (lkr0521h) staining protocol: 400 l of bd leucocount reagent [lot 0294545 expiry date 31/03/22] + 100l of our sample in a bd trucount tube [lot n°20276, 48 600 beads, expiry date 31/10/22].

• Brand Name: BD LEUCOCOUNT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 12193696
• Report Number: 2916837-2021-00313
• Device Sequence Number: 13826338
• Product Code: GKZ
• UDI-Device Identifier: 00382903405237
• UDI-Public: 00382903405237
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: BK970046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 340523
• Device Catalogue Number: 340523
• Device Lot Number: 0329583
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1