MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE TEST STRIPS; GLUCOSE OXIDASE, GLUCOSE

Catalog Number	42214
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
"glucometers using these strips were reading less than 20 but a different bottle of strips read 142.".
Additional Manufacturer Narrative
No product was returned for evaluation.Retained nova statstrip glucose test strips (lot # 0324008249) were used for the complaint investigation.Testing included five (5) levels of whole blood specimens collected from consenting adults.Five (5) nova statstrip glucose meters were used for the study.Four (4) measurements were performed on each meter for each sample (20 measurements total).Plasma ysi glucose results were used as reference values for the whole blood specimens.Retained nova statstrip glucose test strips (lot # 0324008249) meet the performance acceptance criteria for blood specimens for testing done using retained nova statstrip glucose meters.There were no discrepant values obtained during the testing of retained nova statstrip glucose test strips (lot # 0324008249).The results described in the complaint were not reproduced.A root cause could not be conclusively identified based on the results of the investigation.

• Brand Name: STATSTRIP GLUCOSE TEST STRIPS
• Common Device Name: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 39 manning rd; billerica MA 01821
• Manufacturer Contact: patrick sinclair ; 39 manning rd; billerica, MA 01821 ; 9784393676
• MDR Report Key: 22203947
• Report Number: 1219029-2025-00020
• Device Sequence Number: 6887770
• Product Code: CGA
• UDI-Device Identifier: 20385480422141
• UDI-Public: (01)20385480422141(11)240108(17)260108(10)0324008249
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: 01/08/2026
• Device Catalogue Number: 42214
• Device Lot Number: 0324008249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White