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	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through investigation the cause of the reported false positive staphylococcus ludgunesis result is undetermined.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.
Event or Problem Description
On 5/15/2024 customer (b)(6) medical center reported a discrepant result on bc­gp assay.Verigene detected staphylococcus lugdunensis, however maldi detected staphylococcus hominis.Verigene: staphylococcus ludgunesis detected.Maldi: staphylococcus hominis 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 01866301 shows staphylococcus species detected at exposure 24 (ic: 0.4 nc: 0.98) and staphylococcus ludgunesis was detected at exposure 1200 (ic: -0.17 nc: 0.88) with no other elevated signals.Pc1 was detected at exposure 150 (ic: 0.22 nc: 0.97) and pc 2 was detected at exposure 24 with ic and nc values of 0.77 and 0.99 respectively.Camera images were clear bearing no impact on results.This was tested on 5/6/2024 on sp a3.Consumable review.Test cartridge lot: 031824018a extraction tray lot: 0325240188.Utility tray lot: lot information not available.There are no ncmrs associated with the lots utilized.There are seven other erroneous results reported for the staphylococcus ludgunesis target using the lots reported six of which were reported by the same customer at the same time.Due to the amount of complaints, further investigation of test cartridge lot 031824018a will be documented in escalation case (b)(4) and (b)(4).Device review.Verigene processor sp a3: (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 sp s/n (b)(6) had no work performed.There is no indication of a device malfunction.Processor.Verigene reader (b)(6) had no work performed in the past 3 months.Further investigation will be documented in escalation case (b)(4) and (b)(4).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 99.0% (684 not detected/691 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 cl of 99.7-99.9).Further investigation will be documented in escalation case (b)(4) and (b)(4).Conclusion.Through investigation the cause of the reported false positive staphylococcus ludgunesis result is undetermined.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: 19542600
• Report Number: 3006028115-2024-00007
• Device Sequence Number: 18044073
• Product Code: PAM
• UDI-Device Identifier: 00840487101575
• UDI-Public: 00840487101575
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/14/2024

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: 05/15/2024
• Initial Report FDA Received Date: 06/14/2024
• 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