MAUDE Adverse Event Report: BIOMÉRIEUX SA FOSFOMYCIN FM 1024 US B30

Catalog Number 529140

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A customer in the usa notified biomérieux of obtaining qc failure (out-of-range-high results) in association with fosfomycin fm 1024 us b30 - (ref: 529140, lot 1008857310, expiration date 17/07/2022) regarding an atcc® strain.They reported both lot 1008857310 and 1008200670 were not passing qc for pseudomonas aeruginosa atcc® 27853¿: the expected mic results were between 2 and 8 and the customer is getting 32.They reran the test six different times and stated they still did not get the correct result.This complaint is against the lot 1008857310.The customer retested the strain following the methodology and storage guidance provided by biomérieux and the qc with atcc 27853 is still out of range high (mic of 12-16-24, instead of 2-8).No delayed results related to this qc failure have been reported by the customer.As there is no patient associated with this qc strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be created.

Manufacturer Narrative

A customer in the usa notified biomérieux of obtaining qc failure (out-of-range-high results) in association with fosfomycin fm 1024 us b30 - (ref: 529140, lot 1008857310, expiration date 17/07/2022) regarding an atcc® strain.The customer reported a minimum inhibitory concentration (mic) value that was unexpectedly high (12 or 32 ¿g/ml) for an expected etest® range between 2-8 ¿g/ml.Investigation: retained samples from the lot numbers reported (1008857310 and 1008200670) were tested in parallel with an additional internal lot number which was used as a reference.Tests were performed using the qc strains staphylococcus aureus atcc® 29213¿ , enterococcus faecalis atcc® 29212¿ , pseudomonas aeruginosa atcc® 27853¿, and escherichia coli atcc® 25922¿ according to the qc protocol used for the release of each lot number with two different suppliers of mueller hinton (mh) agar media (mhe from biomérieux and mh from becton dickinson).The results obtained for the four strains tested were in accordance with the expected specifications for the investigated etest lots on both media tested.In particular, we obtained mic values for the strain pseudomonas aeruginosa atcc® 27853¿ between 6 and 8 ¿g/ml on the mhe media and between 4 and 6 ¿g/ml on the mh from becton dickinson.(expected qc range for atcc® 27853¿ : 2-8 ¿g/ml).On the 13th december 2021, the investigator searched the biomérieux complaints database to search for any similar, previously reported issues.No other complaints were registered for these lot numbers.Conclusion: the results of quality control obtained during the investigation on the impacted product etest fosfomycin fm 1024 us b30, reference 529140, lot numbers 1008857310 and 1008200670 complied with specifications.Biomérieux did not reproduce the issue reported with the pseudomonas aeruginosa atcc® 27853¿.The package insert states that the choice of media is important for susceptibility testing: ¿the brand chosen should have good batch-to-batch reproducibility to ensure that accurate and reliable mic values are obtained.¿ (table 1 ¿ notes 3).

• Brand Name: FOSFOMYCIN FM 1024 US B30
• Type of Device: FOSFOMYCIN FM 1024 US B30
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12955064
• MDR Text Key: 285538955
• Report Number: 9615754-2021-00289
• Device Sequence Number: 1
• Product Code: JWY
• UDI-Device Identifier: 03573026256739
• UDI-Public: 03573026256739
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981136
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Catalogue Number: 529140
• Device Lot Number: 1008200670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1