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: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.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 (b)(4)) 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 2698 lane b10 and its repeat in run 2714 lane b9 were analyzed.No information was provided possible treatment of the patients between both collections.Moreover, one week passed between collections.The patient sample (b10, run 2698) obtained a strong true positive result for tv in the initial test while the recollection gave negative.Based on the shape of the curve, combined with the strong endpoint (ep) value (~1400), there is no doubt about the tv positive status.It is possible that the patient was treated between both tests.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.Overall, the most probable cause for this discrepancy is that this sample correspond to true positive patient, but the retest was negative due to recollection of the patient or the time elapsed between both tests.Also, possibility of environmental contamination cannot be excluded as other potential cause.The customer mentioned having more tv positive status on instrument ct1266, 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 as this appear a true positive result.Bd quality will continue to monitor for trends.Investigation conclusion: investigation inv-20-plc-242 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, analysis of the customer and manufacturing data.The complaints history showed one other complaint on kit lot 0035173 for ffc error, currently still under 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.The sample from run 2698, lane b10, shows a strong true positive result for the tv target, while the recollection gave negative.There is no doubt about the tv positive status, based on the shape of the curve and endpoint (ep) value.The analysis strongly suggests a true positive result.The discrepancy between tests could be due to treatment of the patient between both tests.This information was not available.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.The most probable cause for this discrepancy is that this sample corresponds to a true positive patient, but the retest was negative due to the recollection of the patient or the time elapsed between both tests.Also, environmental contamination cannot be excluded as other potential cause.Since the customer mentioned having more tv positive results on instrument ct1266, compared to their other instrument, cleaning the instrument could help and is recommended.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.Retain material testing would thus not provide more information than what is available from the final qc test.Overall, the product is not suspected of being in cause.Update risk management file: several discrepant results causes are already documented into the bd max vaginal panel hazard analysis (ha-002-bd max vaginal panel-v.10).The reagent risk assessment remains relevant.Root cause description: the root cause was not identified as this appear a true positive result.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: 10385163
• MDR Text Key: 202246155
• Report Number: 2243072-2020-01216
• 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: 08/10/2020
• 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