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 False Negative Result (1225)

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

Event Date 05/24/2021

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 2 false negative results were obtained by the laboratory personnel.A parallel culture was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: customer complaints about false negative results obtained using max vaginal panel customer has observed a falsely reported negative result for a confirmed positive candida albicans specimen for which neither no info about patient was provided, but customer identified those as false negative because a parallel culture is carried out in routine.

Manufacturer Narrative

H.6.Investigation: the complaint investigation for discrepant results with the bd max vaginal panel (ref 443712) lots 1021801 and 1033588 was performed by the review of the manufacturing records, retain material testing, customer¿s data analysis and verification of complaints history.Review of the manufacturing records of bd max vaginal panel indicated that lots 1021801 and 1033588 were manufactured according to specifications and met performance requirements.Customer reported discrepant results on two specimen samples when using the bd max¿ vaginal panel assay.Negative results were obtained with the bd max¿ vaginal panel assay whereas candida albicans was identified by culture.Customer provided three runs (631, 634 and 652) performed on instrument ct1373.Manual pcr curve adjudication was conducted on the samples identified by the customer.Sample #364 was tested twice (in runs 631 and 634), with two different kit lots, and gave a negative result in both tests.Sample #757 was tested in run 652, and also gave a negative result.However, c.Albicans was found in these two samples by culture.The customer mentioned that no amplification was observed for any of the targets, including the spc.Analysis of the curves showed abnormal high raw fluorescence values for these samples, especially in the cy5.5 channel (spc target) in the 3 runs.The curves obtained for the spc target for all three runs showed a slight increase that passed the threshold to give valid result.However, these curves indicates that they were not the result of true amplification.Amplification of the spc explains why no unr result was obtained.Analysis of the curves in other channels also showed atypical curves for these samples and no amplification for any of the bv targets as well as no amplification of the spc.These observations strongly suggest an issue with the samples.The samples may have contained inhibitory/ interfering substances, or due to an issue from unknown origin.However, manual curve adjudication has limitations; visual examination of pcr curves for low/abnormal signal is a conservative assessment of the data.Overall, based on the information provided by the customer, the issue seems isolated to these 2 patient samples.There is no indication of an increase in complaints for discrepant results for bd max vaginal panel lots 1021801 and 1033588.The root cause was not identified but the presence of interfering or inhibitory substance in sample might be responsible for the customer issue.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.

Event Description

It was reported that while using bd max¿ vaginal panel 2 false negative results were obtained by the laboratory personnel.A parallel culture was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "customer complaints about false negative results obtained using max vaginal panel customer has observed a falsely reported negative result for a confirmed positive candida albicans specimen for which neither no info about patient was provided, but customer identified those as false negative because a parallel culture is carried out in routine.".

• 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
• MDR Report Key: 12028755
• MDR Text Key: 268261750
• Report Number: 3007420875-2021-00022
• Device Sequence Number: 1
• Product Code: PQA
• UDI-Device Identifier: 00382904437121
• UDI-Public: 00382904437121
• Combination Product (y/n): N
• PMA/PMN Number: DEN160001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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: 12/14/2021
• Device Model Number: 443712
• Device Catalogue Number: 443712
• Device Lot Number: 1021801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1