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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd macro-vue¿ rpr card test , 2 false positive results were obtained.There were no results reported to physicians and there was no patient impact.The following information was provided by the initial reporter: "customer has observed that off late they have been facing more reactive samples that is being picked up from their donor pool and when repeated with tppa is negative.".
Additional Manufacturer Narrative
Initial reporter address: (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary: lot : 1335592 catalog 275005 satisfactory results when retention samples were tested for performance using three (3) sera panel numbers of each reactivity.Control lot (2094445) customer batch number (1335592) serum no.13: all lots showed reactive results at 1:1 to 1:4 and reactive minimal at 1:8.Serum no's; 17 - 20: all lots showed reactive results at 1:1 and reactive minimal at 1:4.Serum no¿s.25, 32 and 40: all lots showed reactive minimal results at 1:1 serum no's.1, 8 and 10 all lots showed negative results.Visual inspection was performed to retention samples and no discrepancy were found.Batch record review do not show any discrepancy.Sample was not received.Photo only show package of the material.We were unable to reproduce customer experience.Complaint unconfirmed based of retention test results and batch history record.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.
Event or Problem Description
It was reported that while using the bd macro-vue¿ rpr card test , 2 false positive results were obtained.There were no results reported to physicians and there was no patient impact.The following information was provided by the initial reporter: "customer has observed that off late they have been facing more reactive samples that is being picked up from their donor pool and when repeated with tppa is negative.".

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15229590
• Report Number: 2647876-2022-00186
• Device Sequence Number: 17298844
• Product Code: GMQ
• UDI-Device Identifier: 00382902750055
• UDI-Public: 00382902750055
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: 12/31/2023
• Device Model Number: 275005
• Device Catalogue Number: 275005
• Device Lot Number: 1335592
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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