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

Catalog Number 250100

Device Problem False Negative Result (1225)

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

Event Date 05/05/2022

Event Type  malfunction  

Event 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.

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 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.

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)
• 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: 14457627
• MDR Text Key: 292224167
• Report Number: 1119779-2022-00723
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382902501008
• UDI-Public: 0100382902501008
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 250100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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