MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP GLUCOSE TEST STRIPS

Catalog Number 42214

Device Problem Low Test Results (2458)

Patient Problem Hypoglycemia (1912)

Event Date 11/11/2023

Event Type  malfunction  

Event Description

Receipt of medwatch report: 2400040000-2023-8038 patient blood glucose at 1616 was 64.Hypoglycemia protocol not ordered; team paged requesting protocol be ordered.Patient refusing po intake, 25mls of d50 given per protocol.Recheck after 15 min was 24.Patient completely alert, even agitated during cares.Team paged.Second dose of d50 given.Continuous d5ns initiated per new order.Bg (blood glucose) continued to drop with rechecks, glucometer showed a bg of 27 and then 11.Attempted again with new test strips, bg was 99.

Manufacturer Narrative

Attempts to obtain additional information have not been successful.Should this information become available, a supplemental report will be submitted.

• Brand Name: STATSTRIP GLUCOSE TEST STRIPS
• Type of Device: GLUCOSE TEST STRIPS
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 39 manning rd; billerica MA 01821
• Manufacturer Contact: rebecca figueira ; 39 manning rd; billerica, MA 01821 ; 9784393638
• MDR Report Key: 18429385
• MDR Text Key: 332609364
• Report Number: 1219029-2024-00001
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42214
• Device Lot Number: 0323121249
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1