MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ VAGINAL PANEL; VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM

Model Number 443712

Device Problem Non Reproducible Results (4029)

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

Event Date 08/24/2022

Event Type  malfunction  

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 while using bd max¿ vaginal panel there was a discrepant result.On first run the sample was positive for c.Group, tv and cgla and on repeat the sample was only positive for c.Group.The patient sample was reported as bv negative, c.Group positive, ckru negative, cgla indeterminate and tv indeterminate.There was no patient impact reported.The following information was provided by the initial reporter: customer reported discrepant result 1st run sample was positive for cgroup, tv and cgla.Per our lab protocol, the sample was repeated.On repeat, the sample was only positive for c.Group.Sample reported as bvneg, cgroup pos, ckru neg, c gla indeterminate tv indeterminate.

Manufacturer Narrative

H.6 investigation summary: the complaint investigation for discrepant results with the bd max¿ vaginal panel (ref.(b)(4) ) lot 2117002 was performed by the review of the manufacturing records, customer¿s data analysis and verification of complaints history.Review of the manufacturing records of bd max vaginal panel indicated that lot 2117002 was manufactured according to specifications and met performance requirements.Customer complained about a discrepant result on one sample when the bd max¿ vaginal panel.The sample initially gave a positive result for cgroup, cgla and tv targets in run 3155 lane b10, but when repeated in run 3158 lane a12, it gave only a positive result for the cgroup target.Customer provided the two runs (#3155 and 3158 from instrument cr1423) for investigation.Manual pcr curve adjudication was performed.The initial test (run 3155 lane b10) showed a step dislocation and a high fluorescence in the raw pcr signal, in all channels of the botom cartridge position, compared to the other samples in the same run.The step dislocation caused a cgroup, cgla and tv positive result, and does not appear to be the result of true amplification.When retested in run 3158 a12, there was no issue observed in the fluorescence signal, and the sample remained positive for cgroup target, but tested negative for cgla and tv targets.This cgroup positive result in the repeat test was indicative of a true amplification.The positive results for cgla and tv targets from the initial test (run 3155 lane b10) are caused by an atypical curve.It must be noted that manual pcr curves adjudication has limitations, and the resulting evaluation is a conservative assessment of the data.Bd was unable to identify the cause of these step dislocations, but the issue appears to have been isolated.There is no indication of an increase in complaints for discrepant results for bd max vaginal panel lot 2117002.The root cause of discrepant results was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa).Bd quality will continue to monitor for trends.H3 other text : see h.10.

Event Description

It was reported that while using bd max¿ vaginal panel there was a discrepant result.On first run the sample was positive for c.Group, tv and cgla and on repeat the sample was only positive for c.Group.The patient sample was reported as bv negative, c.Group positive, ckru negative, cgla indeterminate and tv indeterminate.There was no patient impact reported.The following information was provided by the initial reporter: customer reported discrepant result.1st run sample was positive for cgroup, tv and cgla.Per our lab protocol, the sample was repeated.On repeat, the sample was only positive for c.Group.Sample reported as bvneg, cgroup pos, ckru neg, c gla indeterminate tv indeterminate.

• Brand Name: BD MAX¿ VAGINAL PANEL
• Type of Device: VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15418377
• MDR Text Key: 306279236
• Report Number: 3007420875-2022-00048
• Device Sequence Number: 1
• Product Code: PQA
• UDI-Device Identifier: 00382904437121
• UDI-Public: 00382904437121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN160001
• 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: 10/10/2022

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 Expiration Date: 04/25/2023
• Device Model Number: 443712
• Device Catalogue Number: 443712
• Device Lot Number: 2117002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1