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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ ENTERIC BACTERIAL PANEL; SEE H.10
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GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ ENTERIC BACTERIAL PANEL; SEE H.10 Back to Search Results
Model Number 442963
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
It was reported that while using bd max¿ enteric bacterial panel false positives occurred.The following information was provided by the initial reporter in some runs since june, salmonella, shigatoxin, shigella and vibrio were positive.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Common device name: gastrointestinal bacterial panel multiplex nucleic acid-based assay system.
 
Event Description
It was reported that while using bd max¿ enteric bacterial panel false positives occurred.The following information was provided by the initial reporter in some runs since june, salmonella, shigatoxin, shigella and vibrio were positive.
 
Manufacturer Narrative
H.6 investigation summary: review of the manufacturing records of bd max¿ enteric bacterial panel assay indicated that the lot was manufactured according to specifications and met performance requirements.Manual pcr curve adjudication was conducted across the discrepant samples (runs #418/position a5, run #430/position a6, run #455/position a1, run #455/position a1, run #500/positions a1 & a2).Curves analysis showed a late but true amplification, with similar ct, of the shigella, stx and salmonella targets in runs 418/a5, 455/a1 and 500/a2.Moreover, late but true amplification of the shigella and stx targets was observed in runs 430/a6 and 500/a1.No other late amplification of multiple targets was obtained in these runs, but late amplification of single targets was observed in many of the other samples.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Nonetheless, no reagents issue is suspected.The root cause was not identified.However, an environmental / cross contamination can explain the customer¿s positives results in the initial tests.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 lots 2018217, 2067775 and 2110896.Bd cannot confirm the complaint based on the investigation that was performed.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 bd max¿ enteric bacterial panel false positives occurred.The following information was provided by the initial reporter in some runs since june, salmonella, shigatoxin, shigella and vibrio were positive.
 
Manufacturer Narrative
H6: investigation summary: positive results were obtained on initial test for some targets but when repeated, the samples gave negative results for all targets.A list of samples was provided showing that discrepant results were obtained on 5 samples while using 3 different kit lots (lots 2018217, 2067775 and 2110896).Thus, the 3 lots were investigated.Complaint history review revealed no other complaint on the bd max¿ ebp kit from lots 2018217, 2067775 and 2110896.Four other complaints for false positive and discrepant results with the bd max¿ ebp assay were filed in the last twelve months, for various targets for which sample at the assay limit of detection and contamination were identified as potential causes.Based on the complaint review, no reagents issue was identified.No anomaly was observed, in bhr review of bd max¿ ebp assay lots 2018217, 2067775 and 2110896 which could have a link with the customer issue.Also, all three kits met the release specifications and qc results were within the trends.The retain material did not need to be tested since it would not provide more information than what is available from the final qc test.A gross product contamination would have been detected by the final qc test, which is not the case.No sample was received for investigation.Four runs were received for investigation and analyzed with bancs algorithm simulation software.Manual pcr curve adjudication was conducted.Curves analysis showed a late but true amplification, with similar ct, of the shigella, stx and salmonella targets in runs 418 a5, 455 a1 and 500 a2.Moreover, late but true amplification of the shigella and stx targets was observed in runs 430 a6 and 500 a1.No other late amplification of multiple targets was obtained in these runs, but late amplification of single targets was observed in many of the other samples.Also, it was observed that the runs contain a positive control, but no negative control, and the amplification curves of multiple positive targets occurred at similar ct for multiple targets, suggesting a contamination issue through environmental or cross contamination introduced during the positive control preparation at the customer¿s site.The curves were also analyzed by the bd instrument quality engineer, and he also suspected the same cause.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Based on the investigation, bd is unable to confirm the exact cause of the issue although no reagents issue is suspected.H3 other text: see h10.
 
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Brand Name
BD MAX¿ ENTERIC BACTERIAL PANEL
Type of Device
SEE H.10
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 Key15476697
MDR Text Key303345865
Report Number3007420875-2022-00056
Device Sequence Number1
Product Code PCI
UDI-Device Identifier00382904429638
UDI-Public00382904429638
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K140111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/06/2023
Device Model Number442963
Device Catalogue Number442963
Device Lot Number2067775
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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