MAUDE Adverse Event Report: IVQA MEDIUM COMPLEXITY MEDIA TEST KIT; CULTURE MEDIA, MULTIPLE BIOCHEMICAL TEST

Lot Number 200812

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2021

Event Type  malfunction  

Event Description

Ivqa's medium complexity media test kit lot # 200812, exp: 08/31/2023 is contaminated and caused media fill samples submitted for analysis to become turbid and allow growth of gram negative organisms.All of the media fill samples i submitted to us microsolutions failed due to this contamination.I contacted the company (ivqa) and they confirmed that the above lot number had problems and they stated they were sending me 15 replacement kits of a different lot.

• Brand Name: MEDIUM COMPLEXITY MEDIA TEST KIT
• Type of Device: CULTURE MEDIA, MULTIPLE BIOCHEMICAL TEST
• Manufacturer (Section D): IVQA; 21803 cactus ave ; ste h; riverside CA 92518
• MDR Report Key: 11372055
• MDR Text Key: 233481553
• Report Number: MW5099562
• Device Sequence Number: 1
• Product Code: JSE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2023
• Device Lot Number: 200812
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1