MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) KIT BD MAX EXT ENTERIC BACTERIAL PANEL; GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM

Catalog Number 443812

Device Problem False Positive Result (1227)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

It was reported that while using kit bd max ext enteric bacterial panel there were multiple false positives reported, occurrences unknown.No patient impact reported.The following information was provided by the initial reporter: she faced higher positive rate than usual recently, so she sent one of pos specimen to commercial lab (specimen from run1781/a8, shigella pos) but the result was neg.Since signal looks strong enough, i explained inconsistency may be caused by handling from commercial lab (they use manual rt-pcr system).She doesn¿t have the same specimen no more so couldn¿t do re-test on bd max.Today i suggested to retest on max of another pos sample from run1782, the result is run1785.Run1782, a11: shigella, salmonella double pos run1782, a12: salmonella only pos.

Manufacturer Narrative

B3: date of event is unknown.The date received by manufacturer has been used for this field.E.1.Initial reporter facility name: (b)(6) h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been corrected: b.5: it was reported that while using kit bd max¿ enteric bacterial panel there were multiple false positives reported, occurrences unknown.No patient impact reported.The following information was provided by the initial reporter: she faced higher positive rate than usual recently, so she sent one of pos specimen to commercial lab (specimen from run1781/a8, shigella pos) but the result was neg.Since signal looks strong enough, i explained inconsistency may be caused by handling from commercial lab (they use manual rt-pcr system).She doesn¿t have the same specimen no more so couldn¿t do re-test on bd max.Today i suggested to retest on max of another pos sample from run1782, the result is run1785.Run1782, a11: shigella, salmonella double pos.Run1782, a12: salmonella only pos.D1: medical device brand name: bd max¿ enteric bacterial panel.D2a: common device name: gastrointestinal bacterial panel multiplex nucleic acid-based assay system.D2b: medical device type: pci.D4.Unique identifier (udi) #: (b)(4).D4.Medical device lot#: 3088948.D4.Medical device expiration date: 2024-aug-03.H4.Device manufacture date: 2023-mar-29.G5.Pma/510(k)#: k140111.H.6 investigation summary: the complaint investigation for discrepant results when using the bd max¿ enteric bacterial panel assay (ref.(b)(4) from lot 3088948 was performed by the review of the manufacturing records, review of customer¿s data and by the complaint¿s history review.Review of the manufacturing records of bd max¿ enteric bacterial panel assay indicated that lot 3088948 was manufactured according to specifications and met performance requirements.Customer complained about positive samples that tested negative upon retest when using the bd max¿ enteric bacterial panel kit lot 3088948 used in combination with the bd max¿ extended enteric bacterial panel kit lot 2319896.Since positive results were obtained on the top position of the cartridges which corresponds to the targets of the bd max¿ enteric bacterial panel kit lot #3088948, the complaint was instead investigated on this bd max¿ enteric bacterial panel.Customer provided three run files #1781, 1782 and 1785 from instrument ct1581 for investigation.Manual pcr curve adjudication was conducted across the discrepant results (sample a08 run #1781, sample a11 run #1782, sample a11 run #1785 and sample a12 run #1785).Analysis of pcr curves of sample a08 from run #1781 showed a step dislocation in the raw pcr signal which generated positive results.It is unlikely that the step dislocations are due to true amplification and a root cause could not be identified.The sample a11 of run #1785 appears to be the repeat test of sample a08 from run #1781 since both accession number are the same.Analysis of pcr curves of sample a11 from run #1785 showed no anomaly with strong amplification for the spc (cy5.5 channel), but without amplification in the rox channel (shigella target).Curves analysis does not suggest any reagents issue.Bd is unable to explain the discrepancy between initial (a08/run 1781) and re-test (a11/run 1785) result.Although a sample mix-up or sample storage conditions cannot be excluded, no information was provided to allow for further investigation.Analysis of pcr curves of a11 from run #1782 showed no anomaly with expected amplification patterns of the spc (cy5.5 channel), shigella (rox channel) and late salmonella (vic channel) targets, all considered as true amplifications.No issue is suspected, reagents and results are as expected.According to the complaint text, sample a12 from run #1785 is a repeat of sample a11 from run #1782.Unlike initial result, the repeat test was negative for the shigella target.Manual pcr curve adjudication of the sample a12 from run #1785 showed no anomaly with strong amplification from the spc (cy5.5 channel) and salmonella (vic channel) and no amplification for shigella (rox channel).No issue is suspected.Although bd is unable to confirm the cause for this discrepancy, a sample at the assay limit of detection, a sample contamination, a sample mix-up or inadequate sample storage conditions cannot be excluded.Overall, based on the investigation and available information, bd is unable to find the exact cause of the customer¿s discrepant results.Despite one unusual curve, initial results of all the samples analyzed appear to be true positive results.Nonetheless, manual curve adjudication has limitations; visual examination of pcr curves is a conservative assessment of the data.Nonetheless, no reagents issue is suspected.The root cause was not identified.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd max¿ enteric bacterial panel assay lot 3088948.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) since no new hazard was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

Event Description

It was reported that while using kit bd max¿ enteric bacterial panel there were multiple false positives reported, occurrences unknown.No patient impact reported.The following information was provided by the initial reporter: she faced higher positive rate than usual recently, so she sent one of pos specimen to commercial lab (specimen from run1781/a8, shigella pos) but the result was neg.Since signal looks strong enough, i explained inconsistency may be caused by handling from commercial lab (they use manual rt-pcr system).She doesn¿t have the same specimen no more so couldn¿t do re-test on bd max.Today i suggested to retest on max of another pos sample from run1782, the result is run1785.Run1782, a11: shigella, salmonella double pos.Run1782, a12: salmonella only pos.

• Brand Name: KIT BD MAX EXT ENTERIC BACTERIAL PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17927355
• MDR Text Key: 325585662
• Report Number: 3007420875-2023-00095
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• UDI-Public: 00382904438128
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K140111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2023
• 2 Devices were Involved in the Event: 1 2

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: 06/01/2024
• Device Catalogue Number: 443812
• Device Lot Number: 2319896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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