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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS
• Manufacturer (Section D): MERIDIAN BIOSCIENCE, INC.; 3471 river hills drive; cincinnati OH 45244
• MDR Report Key: 6933518
• Report Number: 1524213-2017-00002
• Device Sequence Number: 16264156
• Product Code: NJR
• UDI-Device Identifier: 00840733101342
• UDI-Public: (01)00840733101342(17)180414(10)280350J052
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 3 DA