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

Model Number	270333
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while testing with the bd macro-vue¿ rpr card antigen suspension, discrepant results were obtained.The result was positive while confirmatory testing with a competitor's reagent produced a negative result.Positive result was reported out; there was no report of patient impact.The following information was provided by the initial reporter: customer in (b)(6) received a (1 : 32) titer for one of the patient samples while (b)(6) did the rpr test for this patient using competitor's reagents, and obtained a titer of (1 : 1); patient result was reported as (1 : 32);.
Additional Manufacturer Narrative
Exact date of event is unknown.Information provided: "this test was done in (b)(6) 2021" a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary satisfactory results when retention samples were tested for performance using three (3) sera panel numbers of each reactivity.Control lot (1335592) customer batch number (1123493) serum no.11: all lots showed reactive results at 1:1 to 1:4 and reactive minimal at 1:8.Serum no; 16: all lots showed reactive results at 1:1 and reactive minimal at 1:2.Serum no; 17: all lots showed reactive results at 1:1 to 1:2 and reactive minimal at 1:4.Serum no¿s.29, 32, 34 all lots showed reactive minimal results at 1:1 to 1:2.Serum no¿s.3,7,10: all lots showed negative results.Complaint is unconfirmed based on retention samples and batch history record review.No returned goods received.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process cgg.H3 other text : see h10.
Event or Problem Description
It was reported that while testing with the bd macro-vue¿ rpr card antigen suspension, discrepant results were obtained.The result was positive while confirmatory testing with a competitor's reagent produced a negative result.Positive result was reported out; there was no report of patient impact.The following information was provided by the initial reporter: customer in clinical labs of hawaii received a (1 : 32) titer for one of the patient samples while doh of hawaii did the rpr test for this patient using competitor's reagents, and obtained a titer of (1 : 1); patient result was reported as (1 : 32);.

• Brand Name: BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13765801
• Report Number: 2647876-2022-00063
• Device Sequence Number: 3892235
• Product Code: GMQ
• UDI-Device Identifier: 30382902703335
• UDI-Public: 30382902703335
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 03/31/2022

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 Expiration Date: 05/31/2023
• Device Model Number: 270333
• Device Catalogue Number: 270333
• Device Lot Number: 1123493
• 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: 02/18/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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