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

Model Number GXGBS-LB-10

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

Patient Problems Feeding Problem (1850); Pulmonary Dysfunction (2019); Septic Shock (2068); Unspecified Respiratory Problem (4464)

Event Date 06/13/2023

Event Type  Injury  

Event Description

Us customer contacted cepheid to discuss discrepant results with xpert gbs-lb.On (b)(6) 2023, the customer collected a vaginal/rectal swab from the patient.The customer mixed the eswab with inversion and then pipetted 200ul of the eswab into the lim broth (remel todd hewitt w/cna) and incubated for 18 hours.On (b)(6) 2023, the customer then processed the lim broth per pi and ran it on xpert gbs-lb, which resulted in gbs negative.This was reported to the md.On (b)(6) 2023, the customer subbed the original eswab to remel sheep blood agar.On the same day, the customer also decided to use the same eswab to inoculate a brand-new lim broth vial with 200ul of the eswab.Customer did not inform how original swab was stored in between inoculations.Due to the newborn baby of the patient being symptomatic, the customer did not trust this result and decided to run the original enriched lim broth again.On (b)(6) 2023, the customer then processed the lim broth per pi and ran it on xpert gbs-lb, which resulted in gbs negative.This was not reported to the md.The customer then decided to try running this sample again on the original enriched lim broth again.On (b)(6) 2023, the customer then processed the lim broth per pi and ran it on xpert gbs-lb, which resulted in gbs negative.This was not reported to the md.After waiting for the growth of the bacteria, on (b)(6) 2023, the customer ran the colony on the bruker maldi-tof identification which identified the organism as s.Agalact-group b.The colonies run in duplicate twice; log scores were good and all well above 2.0.On (b)(6) 2023 customer then took the second enriched lim broth that was inoculated on (b)(6) 2023 (incubated for 24 hours) and ran it again on the xpert gbs-lb assay.The customer then processed the new enriched lim broth per pi and ran it on xpert gbs-lb, which resulted in gbs negative.This was not reported to the md.On (b)(6) 2023, the patient's newborn baby had a positive blood culture where group b strep was also identified.Customer received a positive blood culture test on the eplex blood pcr panel for s.Agalactiae.Subsequent culture plates of positive blood culture grew colonies of group b strep on sheep blood agar.Images of the group b strep colonies from subculture of the 2 lim broth cultures on sheep blood agar, were sent to cepheid by the customer on (b)(6) 2023.Customer did not amend the negative result for group b on the genexpert due to never receiving a positive result on the genexpert.Only the original negative result was reported to the md.Customer stated that there was patient impact due to this discrepancy with the newborn baby being symptomatic and septic with group b strep.Customer is not aware of the treatment given to the newborn.Enriched lim broth was all stored at room temperature in between testing.

Manufacturer Narrative

Us customer contacted cepheid to discuss discrepant results with xpert gbs-lb.On (b)(6)2023, the customer collected a vaginal/rectal swab from the patient.The customer mixed the eswab with inversion and then pipetted 200ul of the eswab into the lim broth (remel todd hewitt w/cna) and incubated for 18 hours.On (b)(6) 2023, the customer then processed the lim broth per pi and ran it on xpert gbs-lb, which resulted in gbs negative.This was reported to the md.On (b)(6) 2023, the customer subbed the original eswab to remel sheep blood agar.On the same day, the customer also decided to use the same eswab to inoculate a brand-new lim broth vial with 200ul of the eswab.Customer did not inform how original swab was stored in between inoculations.Due to the newborn baby of the patient being symptomatic, the customer did not trust this result and decided to run the original enriched lim broth again.On (b)(6) 2023, the customer then processed the lim broth per pi and ran it on xpert gbs-lb, which resulted in gbs negative.This was not reported to the md.The customer then decided to try running this sample again on the original enriched lim broth again.On (b)(6) 2023, the customer then processed the lim broth per pi and ran it on xpert gbs-lb, which resulted in gbs negative.This was not reported to the md.After waiting for the growth of the bacteria, on (b)(6) 2023, the customer ran the colony on the bruker maldi-tof identification which identified the organism as s.Agalact-group b.The colonies run in duplicate twice; log scores were good and all well above 2.0.On (b)(6) 2023 customer then took the second enriched lim broth that was inoculated on (b)(6) 2023 (incubated for 24 hours) and ran it again on the xpert gbs-lb assay.The customer then processed the new enriched lim broth per pi and ran it on xpert gbs-lb, which resulted in gbs negative.This was not reported to the md.On (b)(6) 2023, the patient's newborn baby had a positive blood culture where group b strep was also identified.Customer received a positive blood culture test on the eplex blood pcr panel for s.Agalactiae.Subsequent culture plates of positive blood culture grew colonies of group b strep on sheep blood agar.Images of the group b strep colonies from subculture of the 2 lim broth cultures on sheep blood agar, were sent to cepheid by the customer on (b)(6) 2023.Customer did not amend the negative result for group b on the genexpert due to never receiving a positive result on the genexpert.Only the original negative result was reported to the md.Customer stated that there was patient impact due to this discrepancy with the newborn baby being symptomatic and septic with group b strep.Customer is not aware of the treatment given to the newborn.Enriched lim broth was all stored at room temperature in between testing.Discrepant xpert gbs lb result for a patient whose newborn baby developed gbs infection.Patient presented on (b)(6) 2023 with signs of eclampsia - had prenatal care elsewhere, so history besides hbp was unknown.Initial xpert gbs lb test on (b)(6) 2023 from lb#1 culture (vagina/rectal eswab; on-label per ra), was gbs negative and reported to provider.Test showed normal spc & ic curves, no gbs signal or evidence of product malfunction.Per customer, baby was born at 33 weeks on (b)(6) 2023, showed signs of infection on (b)(6) 2023 and blood culture was done.Baby had pbc with s.Agalactiae positive by eplex blood pcr panel; pbc subculture grew gbs.Repeat xpert gbs lb tests with lb#1 and lb#2 were all gbs negative.Customer updated cepheid on (b)(6) 2023 that lb#1 and lb #2 subcultures & eswab culture all grew gbs.Fn xpert gbs lb results may be due to variant gbs strain.Customer asked to send all available samples - eswab, lb#1, lb#2, pbc and gbs isolates to cepheid for investigation.Review of the test result data provided by the customer indicated a false negative result for the mother whose newborn baby developed a gbs infection.The newborn had a transfusion and was treated with antibiotics, considered a serious injury which was contributed to by the false negative result.The original and repeat lb samples and the original eswab sample were returned to cepheid.Portions of the returned lb samples were inoculated into new lb media.The eswab was inoculated onto bap and mcfarland dilutions were made from the growth.The cepheid internal laboratory was able to reproduce the customer's result of gbs negative, for all samples, with the xpert gbs lb test.However, the gbs lb xc result for all samples were gbs positive.On (b)(6) 2023, a provider at the customer site reported that "i understand that the baby (born on 6/9) has improved but continues to have an oxygen requirement." on (b)(6) 2023, a provider at the customer site reported per the nicu physician, the baby is still on oxygen, but they expect that to be discontinued soon.The likely root cause is a gbs isolate with a mutation in the region targeted by the primers and probes of xpert gbs lb impacting test results.A review of in-process testing data summaries showed passing results for all sections.There were no nonconformances identified.A review of complaint trending data showed no trend in complaints for xpert gbs lb lots.The limitations section of the xpert gbs lb instructions for use states: "mutations or polymorphisms in primer or probe binding regions may affect detection of new or unknown variants and may result in a false negative result." there was no evidence of a malfunction with the xpert gbs lb cartridges.Sequencing is currently being performed and a supplemental report will be submitted when sequencing is complete.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 target region.Following the submission of the initial report, the complexity of the infants problems, including the lingering pulmonary complications and feeding complications, were a result of the gbs sepsis.The infant can be at future risk of neurodevelopmental complications, but it is too early to determine if that will bear out in this case.Additionally, annex c, 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 94089
• Manufacturer Contact: somesh lalithraj ; 904 e caribbean dr; sunnyvale 94089 ; 4085488951
• MDR Report Key: 17313221
• MDR Text Key: 319074052
• Report Number: 3004530258-2023-00010
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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 Model Number: GXGBS-LB-10
• Device Catalogue Number: GXGBS-LB-10
• Device Lot Number: 1000858374
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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): Required Intervention