MAUDE Adverse Event Report: BIOMERIEUX SA ETEST® MINOCYCLINE

Catalog Number 516058

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

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer reported using etest minocycline test strips, (b)(4), lot 1003732550 for quality control testing and the results are out of range.Customer retested using a different organism and results are still out of range.Product is only used for quality control testing.No patient samples are associated with this complaint.

Manufacturer Narrative

Biomérieux investigation was conducted.Evaluation of manufacturing qc records indicated proper product performance with no abnormalities noted.Testing of the etest minocycline with atcc strain submittals and internal atcc stock provided minocycline results in the high end of the range within specification.When macro colonies appear, results can be above the range.This occurrence is very rare.Etest minocycline performance is within specifications.

• Brand Name: ETEST® MINOCYCLINE
• Type of Device: ETEST® MINOCYCLINE
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5116265
• MDR Text Key: 27201987
• Report Number: 3002769706-2015-00108
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• 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: 01/21/2018
• Device Catalogue Number: 516058
• Device Lot Number: 1003732550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1