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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM; N/A
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BECTON, DICKINSON & CO. (SPARKS) BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM; N/A Back to Search Results
Catalog Number 445215
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2023
Event Type  malfunction  
Event Description
It was reported that while using bd respiratory viral panel for bd max¿ system rsv channels are negative.The following information was provided by the initial reporter: the curves for the rsv channels are negative.
 
Manufacturer Narrative
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
H.6 investigation summary the complaint investigation for weak mirrored curves when using the bd respiratory viral panel for bd max¿ system (ref.(b)(4) lot: 2229195 was performed by the review of manufacturing records, retain material testing, customer¿s data analysis and verification of complaints history.Review of the manufacturing records of bd respiratory viral panel for bd max¿ system indicated that lot: 2229195 was manufactured according to specifications and met performance requirements.The retain material of bd respiratory viral panel kit for bd max¿ system from lot: 2229195 was tested and all results were as expected.Customer observed weak mirrored curves in the 530/565nm (vic) channel, which detects the respiratory syncytial virus (rsv) target, when a strong cov2 target (475/520nm (fam) channel) amplification is present, when using the bd respiratory viral panel for bd max¿ system.Customer provided runs 2259 and 2260 (pdf files only) from instrument ct1086 for investigation.Based on analysis, samples a10 (run 2259) and a1 (run 2260) were identified as the concerned samples.The manual pcr curves analysis revealed, as described by the customer, that when a strong cov2 target (475/520nm (fam) channel) amplification is present, a weak mirrored curves in the 530/565nm (vic) channel is observed.However, the downward curve observed in the vic channel is not unusual.It is an artefact linked to the assay design, without consequence on rsv detection.Data from the mixed infection/competitive interference study presented in the assay package insert (p0261, table 11), revealed that for the twenty samples co-infected with high load of cov-2 analytes, all gave expected positive rsv results.There is no issue with rsv detection in presence of sars-cov2 target.Based on the investigation and customer data analysis, no false negative result was obtained, and the assay performed as expected.There is no indication of a reagent issue based on the analysis of the complaints received for unusual curves on bd respiratory viral panel for bd max¿ system lot: 2229195.The root cause was not identified since no reagent issue was identified.Bd cannot confirm the complaint based on the investigation that was performed.No corrective and preventive action (capa) was initiated at this time since no new hazard was identified.Bd apologizes for the inconvenience that this may have caused.Bd life sciences quality will continue to monitor for trends.
 
Event Description
It was reported that while using bd respiratory viral panel for bd max¿ system rsv channels are negative.The following information was provided by the initial reporter: the curves for the rsv channels are negative.
 
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Brand Name
BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM
Type of Device
N/A
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key16854234
MDR Text Key314393227
Report Number3007420875-2023-00046
Device Sequence Number1
Product Code GQG
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
N/A
Number of Events Reported1
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 05/25/2023
1 Device was Involved in the Event
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 Date06/25/2023
Device Catalogue Number445215
Device Lot Number2229195
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/09/2023
Initial Date FDA Received05/02/2023
Supplement Dates Manufacturer Received05/25/2023
Supplement Dates FDA Received06/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2022
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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