MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STATSTRIP GLUCOSE TEST STRIP; GLUCOSE MONITORING SYSTEM IVD, POINT-OF-CARE

Model Number	42214
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Hypoglycemia (1912); Hypothermia (1915); Decreased Appetite (4569)
Date of Event	10/31/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
A dhr review was performed.No abnormalities or concerns were observed.The dhr indicated the released product met all specifications.Statstrip glucose meters and test strips are designed to accurately measure the glucose of whole blood collected in heparinized tubes or fresh capillary/venous samples.It was reported that the blood samples were collected in a grey-top tube containing sodium fluoride, which inhibits glycolysis and alters the sample chemistry.This can interfere with the electromechanical measurement principle of the statstrip system.Product is anticipated to return.Upon completion of the investigation, a supplemental report will be submitted.
Event or Problem Description
The complainant reported significant discrepancies between lab values and the statstrip xpress measurement values.Upon arrival, the patient was said to be in an "unconscious" and hypothermic state, body temperature measurement was not possible.The complainant recognizes that there is no causal relationship between patient's expiration and the meter results.Treatment for patient was delayed until laboratory reference value became available.It was reported that the patient expired sometime later.
Additional Manufacturer Narrative
Returned nova statstrip glucose test strips (lot # 324260309) met performance acceptance criteria for blood specimens for testing done using returned and retained nova statstrip glucose meters.Discrepant values were not obtained during the testing of the returned test strips and could not be reproduced.Additionally, it was noted that the blood samples taken contained sodium flouride and was not tested immediately, which inhibits glycolysis and alters the sample chemistry.This can interfere with the electromechanical measuremeant principle of the statstrip system.It is concluded that the test strips and meter did not contribute to the discrepant results.No further action is recommended at this time.Nova will continue to monitor for this or similar events.

• Brand Name: STATSTRIP GLUCOSE TEST STRIP
• Common Device Name: GLUCOSE MONITORING SYSTEM IVD, POINT-OF-CARE
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORP; 39 manning rd; billerica MA 01821
• Manufacturer Contact: destiny sun ; 39 manning rd; billerica, MA 01821 ; 8784393675
• MDR Report Key: 23525794
• Report Number: 1219029-2025-00024
• Device Sequence Number: 10167923
• Product Code: CGA
• UDI-Device Identifier: 20385480422141
• UDI-Public: (01)20385480422141(11)240916(17)270316(10)0324260309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 42214
• Device Catalogue Number: 42214
• Device Lot Number: 0324260309
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR
• Patient Sex: Male