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

Catalog Number	250100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a bd microprobe¿ processor (120 v) had a false negative result.The following information was provided by the initial reporter: it was reported by the customer that false negative results compared to pap results.Customer reporting false negative results compared to pap results.Pap showing positive but the affirm is showing negative results.Confirmatory testing was complete by wet mount.There was no patient impact reported.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd microprobe¿ processor (120 v) had a false negative result.The following information was provided by the initial reporter: it was reported by the customer that false negative results compared to pap results.Customer reporting false negative results compared to pap results.Pap showing positive but the affirm is showing negative results confirmatory testing was complete by wet mount.There was no patient impact reported.
Additional Manufacturer Narrative
H.6 investigation summary: the complaint alleges the affirm instrument (catalog number 250100 and serial number (b)(6) had a "false negative".Workflow was determined to be correct, no qc control issues, and no robot issue was noted.Review of device history record for instrument serial number, (b)(6) is not required as not enough information was available from the customer to provide review criteria.Service history review was not performed for the instrument as this instrument does not receive any service.No samples were returned to quality for investigation, and thus, root cause could not be determined and sample analysis did not occur.If samples are received at a later date, the complaint may be reopened and investigation will occur.Root cause cannot be determined with the information provided.Complaint is unconfirmed as no evidence of an instrument issue was provided.Complaint history for "results¿ was reviewed for the month of (b)(6) 2022.The upper control limit was not breached, and trends were not identified associated with this defect.Review of risk management documentation indicates that the potential risk of the reported failure mode was assessed as severity s4 with potential harm is spread of disease, ectopic pregnancy, pelvic inflammatory disease via document cay-rm-affirm-aph revision 05, lines 2, 3, 8, & 10.H3 other text : see h.10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14457627
• Report Number: 1119779-2022-00723
• Device Sequence Number: 20008482
• Product Code: JQW
• UDI-Device Identifier: 00382902501008
• UDI-Public: 0100382902501008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/03/2022

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 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: 05/05/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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