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

Catalog Number GXGBS-100N-10

Device Problem False Negative Result (1225)

Patient Problem Sepsis (2067)

Event Date 01/14/2024

Event Type  Injury  

Event Description

Uk customer contacted cepheid on 12-mar-2024 to report a questionable negative result on xpert gbs assay.On (b)(6) 2024 patient mother vaginal/rectal swab was collected and tested on xpert gbs per pi at 11:25 pm.On (b)(6) 2024 at 12:21 am, the test result reported: negative.On (b)(6) 2024 after childbirth, the baby exhibited symptoms and was said to be unwell.A blood sample was collected from the baby for blood culture analysis and sent to another lab (specific test performed and date of test not specified).The presence of gbs was confirmed in the blood culture.Diagnosis provided by medical practitioners for both patients was positive for gbs.Both were treated with antibiotics and both patients are now in stable condition.A request was sent to the additional lab for the blood culture to perform further analysis.

Manufacturer Narrative

Uk customer contacted cepheid on 12-mar-2024 to report a questionable negative result on xpert gbs assay.On (b)(6) 2024 patient mother vaginal/rectal swab was collected and tested on xpert gbs per pi at 11:25 pm.On (b)(6) 2024 at 12:21 am, the test result reported: negative.On (b)(6) 2024 after childbirth, the baby exhibited symptoms and was said to be unwell.A blood sample was collected from the baby for blood culture analysis and sent to another lab (specific test performed and date of test not specified).The presence of gbs was confirmed in the blood culture.Diagnosis provided by medical practitioners for both patients was positive for gbs.Both were treated with antibiotics and both patients are now in stable condition.A request was sent to the additional lab for the blood culture to perform further analysis.This customer is the lead obstetrician at this hospital for a uk wide research study called gbs3.The maternity unit is taking part in the study in the intrapartum pcr arm.The customer found out by chance that a baby had developed early onset gbs disease, that the mother had been in the study with a negative pcr, and reported this to cepheid, albeit more than 2 months after the event.The sequence of events is that the mother, who was known to have had gbs cultured and a baby with sepsis in a previous pregnancy, had a negative intrapartum xpert gbs test and was therefore not given intrapartum antibiotics.The birth of the baby was not a normal vaginal delivery.After rupture of membranes the labor did not progress well, and mother eventually had a caesarean section.Her duration of rupture of membranes did not qualify her for intrapartum antibiotics but during surgery it was noted that she appeared to have an amniotic infection and antibiotics were started once the baby was delivered.The baby developed signs of sepsis soon after birth and gbs was cultured from blood cultures.Lumbar puncture was tried on two occasions but failed so it is not possible to know whether the neonate also had meningitis.Wound and placenta cultures from the mother also grew gbs.Review of the test details show a negative result with a late signal.This could reflect either a mutation making it difficult for the test to detect the target, or a sample with low bacterial load below the limit of detection of the test.The isolate from the baby's blood culture has been requested from the laboratory who are seeking permission to send this to cepheid.Baby was discharged stable after two weeks treatment with cefotaxime.The investigation is ongoing.Additional information regarding likely root cause will be provided in a follow-up report once the investigation has been completed.Note for section h3 device evaluated by manufacturer - answer of no is due to the single use of the xpert gbs test and the unavailability of that product lot to be returned to cepheid.

• Brand Name: XPERT GBS
• 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: 19076025
• MDR Text Key: 339777848
• Report Number: 3004530258-2024-00005
• Device Sequence Number: 1
• Product Code: NJR
• UDI-Device Identifier: 07332940000127
• UDI-Public: 07332940000127
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2024

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-100N-10
• Device Lot Number: 1001233061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2023
• 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