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

Catalog Number	42214
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/11/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1219029-2024-00001
• Device Sequence Number: 7772166
• Product Code: CGA
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2025
• Device Catalogue Number: 42214
• Device Lot Number: 0323121249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown