MAUDE Adverse Event Report: BIOMÉRIEUX, SA ETEST MEROPENEM MP 32 WW B30; ETEST® MEROPENEM MP 32 WW B30

Catalog Number 513800

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Note: ref 513800 is not registered with the fda for use in the united states.However, a similar product, ref 513840, is registered with the fda for use in the united states (k010363).A customer in (b)(6) notified biomrieux of discrepant results in association with etest meropenem 32 ww b30 test strips (ref.513800 lot 1007878210).The customer initially tested a patient klebsiella pneumoniae strain using both etest lot 1007878210 and vitek 2 test methods.Vitek 2 obtained a meropenem minimum inhibitory concentration (mic) of =16 g/ml.Etest lot 1007878210 obtained a mic 0.38 g/ml.After obtaining the discrepant mic 0.38 g/ml result, the customer performed quality control (qc) testing on lot 1007878210 using escherichia coli atcc 25922" and pseudomonas aeruginosa atcc 27853".Abnormal ellipses were observed for both organisms and a mic was unable to be determined for either organism.The patient klebsiella pneumoniae strain was then tested using a different etest lot, a resistant mic = 32 g/ml was obtained, which aligned with the vitek 2 result.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomerieux has initiated an internal investigation.

Manufacturer Narrative

A customer from argentina notified biomérieux of obtaining abnormal shapes of ellipse with etest® meropenem (mp 32) (0.002 ¿ 32 g/ml).This issue was observed when testing the quality control (qc) strains escherichia coli atcc® 25922¿ and pseudomonas aeruginosa atcc® 27853¿.The shape of the ellipse was considered atypical, since the ellipse does not intersect the etest strip but ends below the bottom of the strip.The customer tested two qc strains because they observed discrepant results for a klebsiella pneumoniae patient strain between vitek® 2 (mic>=16 mg/ml) and etest mp 32 (mic = 0.38 g/ml).These issues were observed on the etest® meropenem (mp 32) (0.002 ¿ 32 g/ml) b 30, reference 513800, lot number 1007878210, expiry date on 2023-01-22.Investigation: retained sample for the impacted lot number (1007878210) was tested in parallel with one internal lot number used as reference.The tests were performed using the quality control (qc) strains escherichia coli atcc® 25922¿, pseudomonas aeruginosa atcc® 27853¿, haemophilus influenzae atcc® 49766¿, enterococcus faecalis atcc® 29212¿, bacteroides fragilis atcc® 25285¿, bacteroides thetaiotaomicron atcc® 29741¿ and streptococcus pneumoniae atcc® 49619¿ according to the qc protocol used for the release of each lot number.The results obtained for the seven strains tested are in accordance with the expected specifications for the two etest mp 32 lots.Biomérieux did not reproduce the abnormal ellipse shape.A visual check was realized by using a uv lamp on the strips used for the investigation.No issue related to antibiotic gradient was observed on these strips.The batch record of the lot 1007878210 was verified.No observation nor non-conformity during manufacturing and quality control processes was identified.Review of the complaints database did not reveal any other complaints against this lot number.There are no historical reports of performance issues with etest® meropenem (mp 32) (0.002 ¿ 32 g/ml; b 30; ref.513800).In a second step, the investigation tested the customer's product return, three strips of the lot number 1007878210 (ref.513800).Tests were performed on the product return in parallel with the retain sample of this lot and another lot used as reference lot using qc strain escherichia coli atcc® 25922¿ and two other strains with expected mic value higher than the expected mic value of escherichia coli atcc® 25922¿.The reported issue was not confirmed during investigation of the strips returned by the customer nor the reference lot.Conclusion: the results of quality control obtained during our investigation on the impacted etest® meropenem (mp 32) lot 1007878210 complied with specifications.The abnormal shape of ellipse was not reproduced on the retained sample, reference sample, nor on the three strips returned to biomérieux.The performance of etest® ® meropenem (mp 32) (0.002 ¿ 32 g/ml) is within specifications, and as the investigation did not identify any product performance issue, neither corrective nor preventive actions will be implemented.A transfer of antibiotics between two strips can occur if there is contact between the two sides of the strips containing the antibiotics.In this case, a part of the high concentration of antibiotics of a strip could move to the part of the low concentration of antibiotics of the other strip.Customer service reminded the customer that strips must be handled very carefully following package insert recommendations to avoid any degradation of the gradient.

• Brand Name: ETEST MEROPENEM MP 32 WW B30
• Type of Device: ETEST® MEROPENEM MP 32 WW B30
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud; la balme 39390 ; FR 39390
• MDR Report Key: 11345035
• MDR Text Key: 243657018
• Report Number: 9615754-2021-00017
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K010363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Catalogue Number: 513800
• Device Lot Number: 1007878210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1