MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION GLU-TEST STRIPS; GLUCOSE OXIDASE, GLUCOSE

Lot Number 0321102249

Device Problem Component Incompatible (1108)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  malfunction  

Event Description

Lot number ending 2249 glucose testing strips do not register with any glucometer on the unit.Lot pulled and given to sicu manager.Fda safety report id# (b)(4).

• Brand Name: GLU-TEST STRIPS
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION ; waltham MA 02454
• MDR Report Key: 12086298
• MDR Text Key: 259173684
• Report Number: MW5102180
• Device Sequence Number: 1
• Product Code: CGA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0321102249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1