MAUDE Adverse Event Report: BIOMERIEUX SA API - ZYM B REAGENT

Catalog Number 70493

Device Problem Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Customer reported discrepant result for api zym b reagent when identifying streptococcus for streptococcus group d strain.The customer re-tested with two different lots with no results; no color changes detected.There is no report of patient harm or delayed results.

Manufacturer Narrative

Biomérieux internal investigation was conducted.Investigational testing included performance checks of the two (2) incriminated ampules for api® zymb x2 using five (5) batches from retained stock.- lot 1003787970 - lot 1003772470 - lot 1003772410 - lot 1003790030 - lot 1003547280.Non-conformity was observed in the two ampules of interest for all five (5) batches (10 ampules total).Sale of reference 70493 (api® zymb x2) was discontinued via product stop shipment pss #(b)(4).Field safety corrective action (fcsa-2752) and urgent product correction notice (customer letter) was issued to the field december 22, 2015.Capa #(b)(4) was initiated to define the corrective and preventative action plan.

• Brand Name: API - ZYM B REAGENT
• Type of Device: API - ZYM B REAGENT
• 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: 5111701
• MDR Text Key: 27066461
• Report Number: 3002769706-2015-00106
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: CL I, EXEMPT
• 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: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2016
• Device Catalogue Number: 70493
• Device Lot Number: 1003787970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1