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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD COR GX INSTRUMENT; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
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BECTON, DICKINSON & CO. BD COR GX INSTRUMENT; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS Back to Search Results
Catalog Number 443990
Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 while using the bd cor gx instrument erroneous results were reported.The customer stated that ct values are higher than normal causing false negative hpv results to be released.Seventeen patients initially tested as negative, and after repeat testing the results were positive.A false negative result would likely delay follow-up procedures and screenings.A false negative result may also delay the diagnosis of a potentially life-threatening condition in a patient that does not follow the recommended screening guidelines.
 
Manufacturer Narrative
H.6.Investigation: short description complaint: bd cor gx( bd catalog # 443990)- bd cor px (bd catalog #443988) instrument system exhibited discordant hpv patient results to the same specimen set that was subsequently processed on an unapproved method (use of merris minimix laboratory) used by customer facility ((b)(6)) to vortex, placed on to the bd totals multiprocessor and tested on bd viper lt(bd catalog # 442839).Problem statement description: a ct score (value) shift was observed and reported to bd by one (1) customer facility ((b)(6) [norway]) when comparing surepath specimens initially processed on bd cor (less sensitive [higher ct value]) to the same specimen set that was subsequently processed on an unapproved method (use of merris minimix laboratory) to vortex, placed on to the bd totals multiprocessor (to create a molecular aliquot) and tested on bd viper lt (more sensitive [lower ct value]).The observation is exclusive to (b)(6) cor px/gx system (443990 bd cor gx instrument/ 443988 bd cor px instrument- (b)(6)) and is not thought to be an issue universally across all px/gx systems.Dhr review dhr cor px-gx instruments serial (b)(6) confirmed that, instruments were built to production released configuration.No instrument build level anomaly was observed to have caused this issue.As per hazard analysis for the bd onclarity hpv assay on the px/gx cor system baltrm-corhpv-aph , risk index related to potential false negative result is investigate (ye) bd team conducted situation analysis (per cpr-033) /initial investigation on this complaint/ problem statement based on reports from the customer site & initial data analysis ((b)(6) ) bd cor gx-px and vper lt workflow.This bd investigation has revealed two (2) potential root causes/contributing factors: 1.Viper lt ¿ use of the merris minimix (off-label) may mix specimens more vigorously and result in increased removal of cellular and viral material from the collection device (more sensitive [lower ct value ¿ potential false positive]).2.Bd cor ¿ specimen foaming due to excessive mixing (use of the minimix and/or addition [presence] of foaming agents may result in low volume transfers due to liquid level detection errors (less sensitive [higher ct value ¿ potential false negative]).Capa pr 1731362 (cor & viper lt system - discordant results) created on aug 5, 2020 and assigned to chris tesluk.H3 other text: see h.10.
 
Event Description
It was reported while using the bd cor gx instrument erroneous results were reported.The customer stated that ct values are higher than normal causing false negative hpv results to be released.Seventeen patients initially tested as negative, and after repeat testing the results were positive.A false negative result would likely delay follow-up procedures and screenings.A false negative result may also delay the diagnosis of a potentially life-threatening condition in a patient that does not follow the recommended screening guidelines.
 
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Brand Name
BD COR GX INSTRUMENT
Type of Device
INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
Manufacturer (Section D)
BECTON, DICKINSON & CO.
7 loveton circle
sparks MD 21152
MDR Report Key10040225
MDR Text Key191438609
Report Number1119779-2020-00088
Device Sequence Number1
Product Code NSU
Combination Product (y/n)N
PMA/PMN Number
P160037.S005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number443990
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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