MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD MACRO-VUE¿ RPR CARD TEST; ANTIGENS, NONTREPONEMAL, ALL

Model Number	275005
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Report 3 of 3 it was reported that bd macro-vue¿ rpr card test the following information was provided by the initial reporter: 3 incidents of results discrepancy over the last few months there has been some incidents when using the disposable dispenstirs patients appeared nonreactive, but the patients have had a history of being reactive.When we use the mla micropipette to dispense 50 ul there is a significant increase in reactivity.Erroneous result was reported.A nonreactive rpr was reported on a patient; one of our clients tested that patient using the same bd macro-vue rpr kit and received a reactive result.There was no impacted to the patient as our client treated the patient.
Additional Manufacturer Narrative
Initial reporter email: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: catalog 275005, lot number 2311227.Satisfactory results when retention samples were tested for performance using three (3) sera panel numbers of each reactivity.Test was performed using dispentirs and micropipette.No discrepancy was observed.Control lot (3009503) customer batch number (2311227).Enclosed results using micropipettes and dispentirs serum no.(b)(6) : all lots showed reactive results at 1:1 to 1:4 and reactive minimal at 1:8.Serum no.(b)(6) : all lots showed reactive results at 1:1 and reactive minimal at 1:2.Serum no.(b)(6) : all lots showed reactive results at 1:1 to 1:2 and reactive minimal at 1:4.Serum no¿s.(b)(6) : all lots showed reactive minimal results at 1:1 serum no's.(b)(6) : all lots showed negative results.Two photo received, reaction on well can't be defined due to the reflection of the light and unknow time reaction time we were unable to reproduced customer inquired.Antigen performance was as expected.Both test yield in same reactivity device history record (dhr) review was satisfactory; no deviations were reported.In-process and qc testing were within specification.
Event or Problem Description
Report 3 of 3.It was reported that bd macro-vue¿ rpr card test.The following information was provided by the initial reporter: 3 incidents of results discrepancy over the last few months there has been some incidents when using the disposable dispenstirs patients appeared nonreactive, but the patients have had a history of being reactive.When we use the mla micropipette to dispense 50 ul there is a significant increase in reactivity.Erroneous result was reported.A nonreactive rpr was reported on a patient; one of our clients tested that patient using the same bd macro-vue rpr kit and received a reactive result.There was no impacted to the patient as our client treated the patient.

• Brand Name: BD MACRO-VUE¿ RPR CARD TEST
• Common Device Name: ANTIGENS, NONTREPONEMAL, ALL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17028565
• Report Number: 3008352382-2023-00090
• Device Sequence Number: 6908673
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: 00382902750055
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 07/13/2023

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
• Operator of Device: Other
• Device Expiration Date: 11/30/2024
• Device Model Number: 275005
• Device Catalogue Number: 275005
• Device Lot Number: 2311227
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2022
• 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