MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MICROPROBE¿ PROCESSOR (120 V); STATION PIPETTING AND DILUTING, FOR CLINICAL USE

Model Number	250100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.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 using bd microprobe¿ processor (120 v) false positive results were obtained.Samples were retested on 2nd instrument and results were negative.There was no patient impact.The following information was provided by the initial reporter: false positives customer states they have a 2nd instrument and all specimen results were acceptable upon repeat.The instrument in question seems to be getting stuck on certain wells and does not wash the card using all the wells.
Event or Problem Description
It was reported that while using bd microprobe¿ processor (120 v) false positive results were obtained.Samples were retested on 2nd instrument and results were negative.There was no patient impact.The following information was provided by the initial reporter: false positives.Customer states they have a 2nd instrument and all specimen results were acceptable upon repeat.The instrument in question seems to be getting stuck on certain wells and does not wash the card using all the wells.
Additional Manufacturer Narrative
H6: investigation summary: the complaint of "false positive" was reported against the affirm instrument catalog number 250100, serial number (b)(6).Customer reported that the instrument is not moving the pac card along all cassette wells and causing them all the beads to be blue.Customer was requested to remove the program card, clean it off with a kimwipe and use canned air in the card slot.Complaint was closed after three attempt to reach out to the customer.No parts were returned to bd for investigation.Root cause cannot be determined with the information provided.Complaint is confirmed.Investigation consisted of a review of the instrument installation, service history, and related complaint data.No new risks, trends, or hazards were identified.Bd will continually monitor for trend.H3 other text : see h10.

• Brand Name: BD MICROPROBE¿ PROCESSOR (120 V)
• Common Device Name: STATION PIPETTING AND DILUTING, FOR CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12163284
• Report Number: 1119779-2021-01158
• Device Sequence Number: 4377030
• Product Code: JQW
• UDI-Device Identifier: 00382902501008
• UDI-Public: 00382902501008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K923268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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 Model Number: 250100
• Device Catalogue Number: 250100
• 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: 06/16/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• 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