MAUDE Adverse Event Report: CEPHEID CEPHEID XPERT GBS-LB; GBS RT-PCR TEST

Catalog Number GXGBS-LB-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Respiratory Distress Syndrome of Newborns (2046); Septic Shock (2068); Meningitis (2389); Convulsion/Seizure (4406)

Event Date 08/09/2023

Event Type  Injury  

Event Description

Us customer contacted cepheid to discuss discrepant results with xpert gbs lb v1 assay.On (b)(6) 2023, patient 1 sample 1 genital sample was collected for routine gbs testing before delivering her child.The sample was received by the lab, placed into lim broth and incubated overnight.On (b)(6) 2023, a clean swab was placed into broth and then put into the cartridge and ran on the xpert gbs lb assay.The results were gbs negative.The results were reported to the physician.The lab no longer had this specimen, and they did not do a culture at the time of collection/testing.It is unknown if the patient was on any medication as nothing was charted, other than notating she was allergic to red dye.After the baby was born, they began showing symptoms, and both a blood sample and csf sample turned positive for gbs results.The baby became critically ill.These samples were run on biofire.On (b)(6) 2023, patient 1 sample 2s genital swab was collected so the team could recollect and retest the mother.A culture was created from this collection.On (b)(6) 2023, patient 1 sample 2 1st run was processed the same way as above on the xpert gbs lb v1 assay.The results were gbs negative.On (b)(6) 2023, patient 1 sample 2 2nd run 1st retest was removed from fridge (where it had been stored since (b)(6) 2023) and ran on the xpert gbs lb v1 assay.The results were gbs negative.Patient 1 sample 2 was sub cultured, the same way they cultured before/normally, and the team recovered a large amount of gbs.The culture seemed normal, including the looks and biochemical id.The team created "spiked samples" from this culture to test.On (b)(6) 2023 patient 1 sample 3 (samples 2s spiked samples 1st swab) was run on the xpert gbs lb v1 assay.The results were gbs negative.Customer stated inoculated lim broth with known gbs from culture was done roughly, no incubation, no dilution.On (b)(6) 2023 patient 1 sample 4 (samples 2s spiked samples 2nd swab) was run on the xpert gbs lb v1 assay.The results were gbs negative.Customer stated, "with known gbs from patient's culture, made a 0.5 mcfarland in sterile saline.Using 0.1ml of that solution, we added 9.9 ml of saline for a large dilution.Took 10ul of that working dilution and added it to a lim broth and incubated overnight and ran in per pi." all results were reported to the physician.Not all runs were done on-label.The customer stated they used lim broth, however another staff member at the customer site had stated the collection device: fisherbrand amines gel culture transport swab (blue top gel swab and todd hewitt broth from northeast laboratory.The customer stated the baby had been discharged for transfer to another hospital because of gbs and seizure onset.

Manufacturer Narrative

Us customer contacted cepheid to discuss discrepant results with xpert gbs lb v1 assay.On (b)(6) 2023, patient 1 sample 1 genital sample was collected for routine gbs testing before delivering her child.The sample was received by the lab, placed into lim broth and incubated overnight.On (b)(6) 2023, a clean swab was placed into broth and then put into the cartridge and ran on the xpert gbs lb assay.The results were gbs negative.The results were reported to the physician.The lab no longer had this specimen, and they did not do a culture at the time of collection/testing.It is unknown if the patient was on any medication as nothing was charted, other than notating she was allergic to red dye.After the baby was born, they began showing symptoms, and both a blood sample and csf sample turned positive for gbs results.The baby became critically ill.These samples were run on biofire.On (b)(6) 2023, patient 1 sample 2s genital swab was collected so the team could recollect and retest the mother.A culture was created from this collection.On (b)(6) 2023, patient 1 sample 2 1st run was processed the same way as above on the xpert gbs lb v1 assay.The results were gbs negative.On (b)(6) 2023, patient 1 sample 2 2nd run 1st retest was removed from fridge (where it had been stored since (b)(6) 2023) and ran on the xpert gbs lb v1 assay.The results were gbs negative.Patient 1 sample 2 was sub cultured, the same way they cultured before/normally, and the team recovered a large amount of gbs.The culture seemed normal, including the looks and biochemical id.The team created "spiked samples" from this culture to test.On (b)(6) 2023 patient 1 sample 3 (samples 2s spiked samples 1st swab) was run on the xpert gbs lb v1 assay.The results were gbs negative.Customer stated inoculated lim broth with known gbs from culture was done roughly, no incubation, no dilution.On (b)(6) 2023 patient 1 sample 4 (samples 2s spiked samples 2nd swab) was run on the xpert gbs lb v1 assay.The results were gbs negative.Customer stated, "with known gbs from patient's culture, made a 0.5 mcfarland in sterile saline.Using 0.1ml of that solution, we added 9.9 ml of saline for a large dilution.Took 10ul of that working dilution and added it to a lim broth and incubated overnight and ran in per pi." all results were reported to the physician.Not all runs were done on-label.The customer stated they used lim broth, however another staff member at the customer site had stated the collection device: fisherbrand amines gel culture transport swab (blue top gel swab and todd hewitt broth from northeast laboratory.The customer stated the baby had been discharged for transfer to another hospital because of gbs and seizure onset.Initial xpert gbs lb test from lb #1 on (b)(6) 2023 was gbs negative and was reported to the provider.Spc and ic curves were normal, no evidence of product malfunction.Baby was born on (b)(6) 2023, developed symptoms of infection and was critically ill.Baby's csf and blood culture were gbs positive with id confirmed by biofire.Diagnosis was gbs sepsis and meningitis.Baby was treated and initially stable but later developed seizures.Baby was discharged and transferred to university of michigan for a pediatric neurology consult.Customer has no further information regarding the baby's condition after transfer.Lim broth culture from 2nd genital specimen from mother (lb #2) was tested by xpert gbs lb on (b)(6) 2023 and result was gbs negative.Gbs isolates from lb #2 were also gbs negative by xpert gbs lb.Remnant lb #2 received from customer and tested in cepheid labs on (b)(6) 2023 was gbs negative by xpert gbs lb and gbs positive by xpert gbs lb xc.Gbs isolates will be sent for sequencing at a 3rd party site.The determination is a false negative with the likely root cause being a potential mutation in xpert gbs lb target region.This will be further investigated and determined by sequencing.A supplemental report will be submitted once sequencing has been completed.Based on the product safety reference for xpert gbs lb, the severity of harm for a false negative result is considered permanent injury.Note for section h3 device evaluated by manufacturer - answer of no is due to the single use of the xpert gbs lb test and the unavailability of that product lot to be returned to cepheid.

Manufacturer Narrative

Sequencing has been completed and the following determination has been made: sequencing revealed a mutation that prevented binding of the xpert gbs lb primer and probe.The discrepancy is false negative gbs result.The root cause is a mutation in the xpert gbs lb region.Additionally, annex d and annex e codes have been updated to reflect the completion of the investigation.

• Brand Name: CEPHEID XPERT GBS-LB
• Type of Device: GBS RT-PCR TEST
• Manufacturer (Section D): CEPHEID; 904 e caribbean dr; sunnyvale CA 94089
• Manufacturer (Section G): CEPHEID; 904 e caribbean dr; sunnyvale CA 94089
• Manufacturer Contact: somesh lalithraj ; 904 e caribbean dr; sunnyvale, CA 94089 ; 4085488951
• MDR Report Key: 17653313
• MDR Text Key: 322318772
• Report Number: 3004530258-2023-00014
• Device Sequence Number: 1
• Product Code: NJR
• UDI-Device Identifier: 07332940000882
• UDI-Public: 07332940000882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GXGBS-LB-10
• Device Lot Number: 1000876075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other