MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE, INC. ILLUMIGENE GROUP B STREPTOCOCCUS DNA AMPLIFCATION ASSAY; NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS

Model Number 280350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fever (1858)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

Final quality control testing documentation review completed; product release specifications were satisfied.Certificate of analysis issued may 04, 2017.Evaluation of retain kit from same lot completed on 09/07/2017.Retain kit testing performed using qualified quality control positive specimens.Reported positive control results were as expected.Trending complaint review completed by technical support personnel.No other false positive complaints reported for lot number 20350j052.This is the first reported complaint for lot number 280350j052.Event maintained in meridian bioscience, inc.Customer complaint (b)(4).

Event Description

A (b)(6) old baby came to ((b)(6) hospital) ed with fever.Spinal tap and blood cultures were drawn.Csf and blood culture were positive for group b strep.Baby was transferred to (b)(6) neonatal icu and was on ventilator.

• Brand Name: ILLUMIGENE GROUP B STREPTOCOCCUS DNA AMPLIFCATION ASSAY
• Type of Device: NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS
• Manufacturer (Section D): MERIDIAN BIOSCIENCE, INC.; 3471 river hills drive; cincinnati OH 45244
• Manufacturer (Section G): MERIDIAN BIOSCIENCE, INC.; 3471 river hills drive; cincinnati OH 45244
• Manufacturer Contact: susan rolih ; 3471 river hills drive; cincinnati, OH 45244 ; 5132713700
• MDR Report Key: 6933518
• MDR Text Key: 89149626
• Report Number: 1524213-2017-00002
• Device Sequence Number: 1
• Product Code: NJR
• UDI-Device Identifier: 00840733101342
• UDI-Public: (01)00840733101342(17)180414(10)280350J052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Expiration Date: 04/14/2018
• Device Model Number: 280350
• Device Catalogue Number: 280350
• Device Lot Number: 280350J052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 3 DA