MAUDE Adverse Event Report: BECTON DICKINSON BD MAX VAGINAL PANEL; SEE H.10

Model Number 443712

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

For oem manufacturing sites: (b)(4).Common device name: vaginitis and bacterial vaginosis nucleic acid detection system.(b)(4).Investigation summary: the complaint investigation for discrepant results when using the bd max vaginal panel (ref 443712) lot 0035173 was performed by the review of the manufacturing records, customer¿s data analysis and verification of complaints history.Review of the manufacturing records indicated that the qc results were compliant.The customer obtained a tv positive result and questioned the results.Sample in run 2697 lane a10 and its repeat in run 2724 lane a2 were analyzed.No information was provided possible treatment of the patients between both collections.Moreover, one week passed between collections.Analysis shows that all the curves in the bot reader of lane a10 (run 2697) had the same profile.When the curves are verified in details the same glitch is visible around cycle 15 in all channels, causing an increase in each channel.This glitch caused an interruption in background correction, generating an increase of fluorescence in the curves, resulting in a positive result for tv and cgla.However, this does not correspond to true positive results.This glitch could have been caused by a bubble or a punctual instrument issue but the exact cause could not be confirmed.Because the customer mentioned having multiple tv pos results in a short time, the rate of tv positives by month was evaluated.This analysis revealed a stable rate of tv throughout time, including the month of july.The customer mentioned having more tv positive status on instrument (b)(4), which could not be confirmed.There is no complaint trend for discrepant results for the bd max¿ vaginal panel kit lot 0035173.The root cause was not identified but an isolated instrument issue is suspected.Bd quality will continue to monitor for trends.Investigation conclusion: investigation (b)(4) was completed on 2020-08-03.It concerned discrepant trichomonas vaginalis (tv) results with the bd max¿ vaginal panel assay, on one sample, using kit lot 0035173.The investigation consisted in verification of the complaints history, as well as analysis of the customer and manufacturing data.The complaints history showed one other complaint on kit lot 0035173 for ffc errors, still in investigation.The complaints history showed that, in the last twelve months, several other complaints were received for discrepant results and were caused by various issues, including off label use, customer training, samples at the limit of detection of the assay (lod), atypical curves, interfering substances and instrument issues.Review of the complaints history did not identify any product issue.The final kit qc of bd max¿ vaginal panel kit lot 0035173 performed as expected, with no anomaly.Moreover, kit lot 00335173 qc results were within the trends for the last twelve months.Sample from run 2697, lane a10, with the positive tv result, showed that all the curves in the bot reader of the cartridge have the same glitch around cycle 15.This glitch caused an interruption in background correction, generating an increase of fluorescence in all channels, resulting in a positive result for tv and cgla targets, for which the threshold was passed.However, both results do not correspond to true positive results.Retain material did not need to be tested.Indeed, the final qc results did not show any false results.Moreover, gross product contamination would have been detected by the final qc test.Therefore, retain material testing would not provide more information than what is available from the final qc test.Overall, the product is not suspected to be in cause.The customer also mentioned having more tv positive results in a short time.However, the rate of tv positives was reviewed, and it is stable in time, without any big fluctuations since the beginning of use.Based on this analysis, the glitch seems caused by a bubble or a punctual instrument issue.Update risk management file: several discrepant results cause are already documented into the bd max vaginal panel hazard analysis ((b)(4)).However an isolated instrument issue is suspected thus the reagent risk assessment remains relevant.Root cause description: the root cause was not identified but an isolated instrument issue is suspected.Rationale: no capa required.

Event Description

It was reported that while using bd max¿ vaginal panel false positive results were obtained by the laboratory personnel.The provider questioned the positive results and the patient returned for sample recollection.Upon repeat the new sample was negative.The patient was not treated based on the initial erroneous result.

• Brand Name: BD MAX VAGINAL PANEL
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10382826
• MDR Text Key: 207113352
• Report Number: 2243072-2020-01215
• 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
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/30/2021
• Device Model Number: 443712
• Device Catalogue Number: 443712
• Device Lot Number: 0035173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• 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
• Patient Outcome(s): Other