MAUDE Adverse Event Report: BIOMÉRIEUX, SA TODD HEWITT BROTH + ANTIBIOTICS (TODD H-T)

Model Number	TODD H-T
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: todd-hewitt broth + antibiotics is a selective enrichment broth for the detection of group b streptococci in pregnant women (1, 2, 3, 4).This broth can also be used for the enrichment of s.Aureus within the scope of methicillin-resistant s.Aureus detection.Issue description: a customer in italy notified biomérieux of no growth in association with todd hewitt broth + atb 20t 9ml (ref.(b)(4), lot.1009554700, exp.Date: 6/20/2023).The customer reported an anomaly in the growth of streptococcus agalactiae after enrichment in broth with (b)(6) ((b)(6)).In particular, the customer observed a massive growth in gbs and cna from direct seeding of the vaginal swab before the broth enrichment procedure and the absence of growth of the same streptococcus agalactiae from seeding on gbs and cna after broth enrichment.The laboratory procedure foresees both the direct seeding of vaginal and rectal swabs on cna and gbs and the enrichment in broth, followed by incubation in a thermostat for 18-24h and the subsequent seeding from broth again on cna and gbs.Streptococcus agalactiae identification was confirmed with vitek 2 card.The customer was able to report but there was discomfort.At the time of the global assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.An investigation has been initiated.
Additional Manufacturer Narrative
Context: a customer in italy notified biomérieux of no growth in association with todd hewitt broth + atb 20t 9ml (ref.42116, lot.1009554700, exp.Date: 6/20/2023).The customer reported an anomaly in the growth of streptococcus agalactiae after enrichment in broth with todd hewitt (todd h-t).There was massive growth of streptococcus agalactiae on gbs and columbia anc agar (cna) from direct seeding of a vaginal swab, then no growth of the same streptococcus agalactiae on gbs and cna after broth enrichment.The strain and the tubes in question were not available for investigation.Photos are available.Investigation: batch history record and complaint trend analysis, there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results: 1.Lot review analysis: lot number 1009554700 was manufactured on 24 aug 2022.2085 kits (20 tubes / kit) have been released with an expiration date of 20 jun 2023.The quality control of the weight and the appearance of the product complied with specifications for the duration of the manufacturing process.Quality controls are performed before releasing the product.The following controls were performed: the quality controls complied with specifications for all the atcc controls tested for microbiological activity.The following strains were tested: good growth for streptococcus agalactiae nctc (b)(6) and streptococcus agalactiae nctc (b)(6).And total inhibition was observed for the following strains, escherichia coli atcc (b)(6) and proteus vulgaris atcc (b)(6).All the quality controls conformed with specifications.Control of microbiological condition and appearance, tubes were incubated at 33-37°c for 14 days.The results are within specification.Ph control.The results are within specification.Control of the % transmission.All the tubes tested complied with specifications.The quality control of lot 1009554700, reference (b)(6) is compliant.No recorded nonconformance involving a product performance issue for this lot.The lot review did not identify an explanation for the fertility defect reported.2.Retained samples analysis: biomérieux retains samples of every lot number released to the market.The retained samples for the impacted lot number 1009554700 were tested in parallel with a reference lot (reference (b)(4), lot 1009477260, expiry date 04-may-2023).The bacteriological performance of the lot in question was checked with control strains, streptococcus agalactiae nctc (b)(4) and streptococcus agalactiae nctc (b)(4).Growth from 18-20 hours and very good growth at 24 hours +/- 2 hours of incubation were obtained.And a total inhibition was observed for escherichia coli atcc (b)(4) and proteus vulgaris atcc (b)(4) at 24 hours +/- 4 hours of incubation.The reported issue, namely, no growth of streptococcus agalactiae after enrichment with todd hewitt broth + antibiotics (todd h-t) was not reproduced during this investigation with the impacted lot 1009554700, expiry date on 20-jun-2023.Conclusion: analysis of lot number records indicated that the impacted lot, 1009554700, complied with biomérieux specifications and no nonconformities impacting product performance were recorded during the manufacturing process.Retained sample plates from the impacted lot number and a reference lot number were tested.Streptococcus agalactiae nctc (b)(4) and streptococcus agalactiae nctc (b)(4) showed a growth from 18-20 hours and a good growth at 24 hours +/- 2 hours of incubation.

• Brand Name: TODD HEWITT BROTH + ANTIBIOTICS (TODD H-T)
• Common Device Name: TODD HEWITT BROTH + ANTIBIOTICS (TODD H-T)
• Manufacturer (Section D): BIOMÉRIEUX, SA; 5 rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer (Section G): BIOMÉRIEUX, SA; 5, rue des aqueducs; craponne 69290 ; FR 69290
• Manufacturer Contact: céline lacroix gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16673459
• Report Number: 9615755-2023-00001
• Device Sequence Number: 5377716
• Product Code: JSD
• UDI-Device Identifier: 03573026118723
• UDI-Public: 03573026118723
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2023
• Device Model Number: TODD H-T
• Device Catalogue Number: 42116
• Device Lot Number: 1009554700
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown