MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® DAPTOMYCIN DPC 256 WW F100

Catalog Number 535018

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported out of range low results for internal quality controls (qc) in association with etest® daptomycin dpc 256 ww f100 (reference 535018) lot 1004343910.The customer stated that when their qc is within range it is always at the very lowest end of the qc range for both the staphylococcus aureus atcc® 29213 and enterococcus faecalis atcc® 29212.The customer reported that when the qc is out of range, it is always lower than expected.The customer reported that results were delayed at least 72 hours for two (2) patients (with vre in the blood) due to the daptomycin qc failing at least twice.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to a patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from canada reported out of range low results for internal quality controls (qc) in association with etest® daptomycin dpc 256 ww f100 (reference 535018) lot 1004343910.An investigation was performed.Testing was performed on retained samples of etest daptomycin dpc 256 ww f100 (lot 1004343910) and etest daptomycin dpc 256 s30 (lot 005932460), in parallel with another batch as a reference (lot 1006198630).Three qc strains were tested: staphylococcus aureus atcc 29213 and enterococcus faecalis atcc 29212 were tested on two mueller hinton media: one lot of mh-e biomérieux and one lot of mh-bd pre-poured.Streptococcus pneumoniae atcc 49619 was tested on one lot of mh blood, produced in-house with bd powder.The customers issue was reproduced with: - staphylococcus aureus atcc 29213: lot 1004343910 and mh-e media had two strips on three at 0.125 ¿g/ml - enterococcus faecalis atcc 29212: all three lots and mh-e media had one or two strips on three at 0.5 ¿g/ml.All data was compliant with: - streptococcus pneumoniae atcc 49619 on mh blood (produced in-house with bd powder.- staphylococcus aureus atcc 29213 and enterococcus faecalis atcc 29212) on mh-bd prepoured as explained in the etest customer information sheet cis 014, daptomycin requires physiologic levels of free calcium (ca2+) for expression of adequate activity.The bioavailable free ca2+ levels in brands and batches of mha powder and commercial mha plates can vary significantly and affect etest dpc results.Conclusion: no loss of performance was found during the investigation.However, it was confirmed that the source of the media could impact the reading of the mic value.This doesn't mean that particular media are not compatible with etest but that the composition is different.Mic values may vary batch to batch and it is important to test qc strains to validate the use of the lot of media.

• Brand Name: ETEST® DAPTOMYCIN DPC 256 WW F100
• Type of Device: ETEST® DAPTOMYCIN DPC 256 WW F100
• Manufacturer (Section D): BIOMERIEUX SA; 3 route de port michaud; la balme les grottes isere 383; FR
• MDR Report Key: 7374737
• MDR Text Key: 103941838
• Report Number: 3002769706-2018-00049
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• PMA/PMN Number: K042392
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 535018
• Device Lot Number: 1004343910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1