MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MACRO-VUE¿ RPR CARD TEST; ANTIGENS, NONTREPONEMAL, ALL

Model Number	275005
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd macro-vue¿ rpr card test that there is a performance issue.The following information was provided by the initial reporter: "we have particular lot number of bd macro-vue syphilis rpr reagent which seems to be performing differently compared to expected performance.Lot number 2013911 with expiry 31/01/24 seems to be more granular in consistency however when tested with a patient sample it is leading to under-reporting of rpr titres.We have compared it to a newer lot 2094445 with expiry 30/04/24 and this is performing as expected.".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Initial reporter phone #: (b)(6).Initial reporter fax #: (b)(6).
Event or Problem Description
It was reported that while using the bd macro-vue¿ rpr card test that there is a performance issue.The following information was provided by the initial reporter: "we have particular lot number of bd macro-vue syphilis rpr reagent which seems to be performing differently compared to expected performance.Lot number 2013911 with expiry 31/01/2024 seems to be more granular in consistency however when tested with a patient sample it is leading to under-reporting of rpr titres.We have compared it to a newer lot 2094445 with expiry 30/04/24 and this is performing as expected.".
Additional Manufacturer Narrative
H.6 investigation summary: material 275005, batch 2013911 satisfactory results when retention samples were tested fo.R performance using three (3) sera panel numbers of each reactivity: control lot (2222697) customer batch number (2013911).Serum no.12: control, returned goods and retention, showed reactive results at 1:1 to 1:4 and reactive minimal at 1:8.Serum no's; 17 ¿ 20 : control, retuned good and retention showed reactive results at 1:1 and reactive minimal at 1:4.Serum no¿s.26, 36 and 40 : control, returned good and retention sample showed reactive minimal results at 1:1.Serum no's.8, 9 and 10: all lots showed negative results.Visual inspection was performed to retention samples and returned goods received, no discrepancy were found.Normal particle size was observed.Dhr batch history records were reviewed with satisfactory results, no deviations were reported.In-process and qc testing were within specification batch record review do not show any discrepancy.Photo was evaluated and normal size of the particle were showed.Complaint unconfirmed based of retention sample, returned goods test results, batch history record review.Special attention should be provided to: antigen storage and use.Sample and room temperature during the test.Type of specimen used: collection and preparation.According of the ¿manual of test for syphilis¿ edition 9.0 the following ¿sources of error¿ had been identified for increase of reactivity or false reactivity for the rpr test.If the time of rotation is too long, test reactivity may be increased.If the card is excessively rotated and tilted (to and fro motions) by hand after removal from the rotator, a false reactive result may occur.If the serum is unevenly spread in the circle, the antigen and the antibody may not mix properly.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.

• Brand Name: BD MACRO-VUE¿ RPR CARD TEST
• Common Device Name: ANTIGENS, NONTREPONEMAL, ALL
• 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: 15788970
• Report Number: 1119779-2022-01386
• Device Sequence Number: 5747483
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: 00382902750055
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 01/31/2024
• Device Model Number: 275005
• Device Catalogue Number: 275005
• Device Lot Number: 2013911
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown