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	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through investigation the cause of the reported false positive staphylococcus ludgunesis and enterococcus faecium result will be investigated under (b)(4).Further investigation for root cause will be documented in escalation (b)(4).The customer site is not performing within the expectations stated in the bc-gp package insert for the staphylococcus ludgunesis target.Although the erroneous result occurred, there was no injury or death to patient.
Event or Problem Description
On 5/13/2024 customer (b)(6) medical center reported a discrepant result on bc-gp assay.Verigene detected staphylococcus lugdunensis, enterococcus faecium, and micrococcus however culture showed no targets detected.Verigene run 1: staphylococcus ludgunesis and enterococcus faecium detected culture: no targets detected.Data review: per verigene id software requirements specification ((b)(4)), 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)(6) shows staphylococcus ludgunesis detected at exposure 1200ms (ic: -0.22 nc: 0.91) and enterococcus faecium detected at exposure 1200ms.Pc1 was detected at exposure 24ms (ic: 0.66 nc: 0.99) and pc 2 was detected at exposure 150 with ic and nc values of 0.23 and 0.98 respectively.Camera images were clear with minor background and no impact on results.This was tested on (b)(6) 2024 on sp a1.Consumable review: test cartridge lot: 031824018a.Extraction tray lot: 031124018b.Utility tray lot: 030824018c.There are no ncmrs associated with the lots utilized.There are 22 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).Device review: verigene processor sp a1: (b)(6).Verigene reader: (b)(6).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 one pm performed.Verigene reader 13224150 had one pm performed.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 nov/2023 to may/2024.There was a negative agreement of 99.2% (1605 not detected/1618 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).The negative agreement for the enterococcus target was 99.2% (1601 not detected/1614 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 enterococcus faecium target is 100% with a confidence interval of 99.7-100%.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 case (b)(4) and (b)(4).Conclusion: through investigation the cause of the reported false positive staphylococcus ludgunesis and enterococcus faecium result will be investigated under (b)(4).Further investigation for root cause will be documented in escalation case (b)(4) and (b)(4).The customer site is not performing within the expectations stated in the bc-gp package insert for the staphylococcus ludgunesis target.Although the erroneous result occurred, there was no injury or death to 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: 19492332
• Report Number: 3006028115-2024-00005
• Device Sequence Number: 12518727
• 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): 06/07/2024

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: 05/13/2024
• Initial Report FDA Received Date: 06/07/2024
• 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