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

Model Number	337166
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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 while testing with bd multitest¿ erroneous results were obtained.Testing with a different lot# provided accurate results.The following information was provided by the initial reporter, translated from spanish to english: lot 15789 not efficient, same sample tested with another lot gave good results.Abnormal double population cd56+cd19+.
Additional Manufacturer Narrative
After further review mfr#2916837-2021-00253 is no longer reportable.This device is for research use only and is not being used for diagnostic testing or patient treatment and is therefore not subject to mdr reporting.
Event or Problem Description
It was reported while testing with bd multitest¿ erroneous results were obtained.Testing with a different lot# provided accurate results.The following information was provided by the initial reporter, translated from spanish to english: lot 15789 not efficient, same sample tested with another lot gave good results.Abnormal double population cd56+cd19+.

• Brand Name: BD MULTITEST
• 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: 11878127
• Report Number: 2916837-2021-00253
• Device Sequence Number: 16408973
• Product Code: GKZ
• UDI-Device Identifier: 00382903371662
• UDI-Public: 00382903371662
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K060375
• 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): 06/18/2021

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: 12/31/2021
• Device Model Number: 337166
• Device Catalogue Number: 337166
• Device Lot Number: 15789
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1