MAUDE Adverse Event Report: BIOMERIEUX, SA CLINDAMYCIN CM 256 WW S30; ETEST CLINDAMYCIN 256

Catalog Number 412315

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomerieux to report low results for enterococcus atcc9213 with etest clindamycin cm 256 test kit ((b)(4), lot 1003765720).Retesting provided the same result using both biomerieux and oxoid atcc 29213.The same etest clindamycin cm 256 product is marketed in the united states under (b)(4).There is no indication or report from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to a patient's state of health.Culture submittals have been requested by biomerieux for internal investigation.

Manufacturer Narrative

Biomérieux internal investigation was conducted.The results of the investigation indicate results at the limit of the compatibility with etest® clindamycin cm 256 (whatever the lot tested) when used in conjunction with mueller hinton e agar.This allows a potential for the underestimation of the mic for qc strains 29213 which can give some values out of range.Based on the investigation results, when using etest® cm 256 test kit in conjunction with mueller hinton e agar, there is a potential for low mic for staphylococcus strains.Intermediate (i) strains could give a false susceptible result (s) or resistant (r) strains could give a false intermediate result (i).Field corrective action ((b)(4)) and corresponding product correction notice (customer letter) were issued to the field 14-dec-15.

• Brand Name: CLINDAMYCIN CM 256 WW S30
• Type of Device: ETEST CLINDAMYCIN 256
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme les grottes isere, 38390 ; FR 38390
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5118070
• MDR Text Key: 27304805
• Report Number: 3002769706-2015-00111
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K913459/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2020
• Device Catalogue Number: 412315
• Device Lot Number: 1003765720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2015
• 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