MAUDE Adverse Event Report: LUMINEX CORPORATION VERIGENE BC-GP NUCLEIC ACID TEST KIT; VERIGENE BC-GP ASSAY

Catalog Number	20-005-018
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through investigation the cause of the reported false positive staphylococcus ludgunesis result will be investigated under (b)(4).Further investigation for root cause will be documented in escalation case (b)(4).Although the erroneous result occurred, there was no noted injury or adverse heath consequences to the patient.
Event or Problem Description
On 6/23/2024 customer (b)(6) medical center brownwood reported a discrepant result on bc-gp assay in response to fsn-0005.Verigene detected staphylococcus lugdunensis, however maldi-tof detected corynebacterium striatum.Verigene: staphylococcus ludgunesis and enterococcus faecium detected.Culture: streptococcus gallolyticus detected.Maldi-tof: corynebacterium striatum detected.Data review: per verigene id software requirements specification (toast-srs-1042), in order for an organism to be detected the ic ratio must be greater than or equal to -0.4 and the nc ratio must be greater than 0.85.Review of test cartridge (b)(4) shows staphylococcus ludgunesis detected at exposure 1200ms (ic: -0.28 nc: 0.87).Pc1 was detected at exposure 24ms (ic: 0.53 nc: 0.99) and pc 2 was detected at exposure 24ms with ic and nc values of 0.23 and 0.98 respectively.Camera images were clear with suspected no impact on results.Test was completed on (b)(6) 2024.Consumable review: test cartridge lot: 031824018a.Extraction tray lot: 031124018b.Utility tray lot: 030824018c.There are no ncs associated with the lots utilized.There are 25 other erroneous results reported for the staphylococcus ludgunesis target using the lots reported.Due to the amount of complaints, further investigation of test cartridge lot 031824018a will be documented in escalation case (b)(4) and hra-24-0007.Device review: verigene processor sp: 18054001.Verigene reader: 22243901.Review of the verigene sp and reader device history was assessed for a time frame of 3 months prior to the reported discrepant result.Verigene processor sp and reader each had one pm performed without issue.There is no indication of a device malfunction.Site performance: a 6-month customer site performance for negative agreement of staphylococcus ludgunesis target was performed from (b)(6) 2024.There was a negative agreement of 99.3% (142 not detected/143 expected not detected).Per the verigene gram positive blood culture nucleic acid test package insert (89-30000-00-782) the expected negative agreement for the staphylococcus ludgunesis target is 100% (with a ci of 99.7-99.9).Based on the expected performance characteristics and data provided by the customer, the customer site is not performing within the package insert expectations, further investigation of test cartridge lot 031824018a will be documented in escalation (b)(4).Conclusion: through investigation the cause of the reported false positive staphylococcus ludgunesis result will be investigated under (b)(4).Further investigation for root cause will be documented in escalation case (b)(4).Although the erroneous result occurred, there was no noted injury or adverse heath consequences to the patient.

• Brand Name: VERIGENE BC-GP NUCLEIC ACID TEST KIT
• Common Device Name: VERIGENE BC-GP ASSAY
• Manufacturer (Section D): LUMINEX CORPORATION; 4088 commercial avenue; northbrook IL 60062
• Manufacturer Contact: jordan smith ; 1224 deming way; madison, WI 53717
• MDR Report Key: 19817898
• Report Number: 3006028115-2024-00016
• Device Sequence Number: 8679782
• Product Code: PAM
• UDI-Device Identifier: 00840487101575
• UDI-Public: 00840487101575
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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 Expiration Date: 09/16/2024
• Device Catalogue Number: 20-005-018
• Device Lot Number: 031824018A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown