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

Model Number 250100

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd microprobe¿ processor (120 v) that there was false positives.The following information was provided by the initial reporter: microprobe - 250100 - all positive results.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd microprobe¿ processor (120 v) that there was false positives.The following information was provided by the initial reporter: microprobe - 250100 - all positive results.

Manufacturer Narrative

H.6 investigation summary the complaint alleges the affirm instrument (catalog number 250100 and serial number (b)(6) ) had a "false positive".Customer reported that they received all suspected false positive results on a single run.Customer also reported that they noticed the cards did not flip all the way up at the end of the run.Bd service specialists followed-up with the customer who confirms that the issue occurred with one run only and the issue was an isolated event.The customer has performed additional runs since the one occurrence, using the same affirm kit and processor, and testing has been satisfactory with no recurrence of the issue.This complaint is unconfirmed as it alludes to a contamination issue.The root cause cannot be determined with the information provided.No samples were expected to be received as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Review of device history record for instrument serial number, a570031 is not required as the issue was not related to the instrument and does not allude a manufacturing error.Service history review was not performed for the instrument as this instrument does not receive any service.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.H3 other text : see h.10.

• Brand Name: BD MICROPROBE¿ PROCESSOR (120 V)
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15811208
• MDR Text Key: 307086413
• Report Number: 1119779-2022-01394
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382902501008
• UDI-Public: 00382902501008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

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 Model Number: 250100
• Device Catalogue Number: 250100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1