MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP; SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

Model Number	1.86
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Blood glucose on patient and the glucometer display went into blue screen.No blood sugar reading noted.Patient was pricked and blood was retrieved, and thus we need to re-prick the patient.Endoscopy team had been using this specific glucometer and the number at the back of the glucometer is #54790.Glucose level was collected and resulted with a different glucometer.

• Brand Name: STATSTRIP
• Common Device Name: SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• MDR Report Key: 18562797
• Report Number: 18562797
• Device Sequence Number: 20864131
• Product Code: JJX
• UDI-Device Identifier: 00385480547901
• UDI-Public: (01)00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/04/2023
• Report Date (Section F): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1.86
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 10/04/2023