MAUDE Adverse Event Report: BIOMERIEUX SA MINOCYCLINE MC 256 US S30

Catalog Number 412407

Device Problem High Readings (2459)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Customer called to report they are using ref.412407, etest minocycline mc 256 us s30 strips which are always at the high end of acceptable range (1 - 1.5).Customer has two boxes of same lot and has repeated quality control testing with the same high results.

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: MINOCYCLINE MC 256 US S30
• Type of Device: MINOCYCLINE MC 256 US S30
• 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: 5101025
• MDR Text Key: 26676428
• Report Number: 3002769706-2015-00099
• Device Sequence Number: 1
• Product Code: JWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K99097
• 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: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• 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: 412407
• Device Lot Number: 1003729230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• 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