MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR PATIENT TESTING

Model Number	1.86
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	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned.The investigation is anticipated but not yet begun.No reported adverse effect to the neonate.Upon completion of the investigation a supplemental report will be submitted.
Event or Problem Description
"while using a glucometer on pediatric patients, three consecutive readings showed results of >600 mg/dl from different two patients.However, the glucometer passed quality control (qc) checks earlier that day.Suspecting an abnormality, the nurse repeated the tests using a different vial of test strips, and the >600 readings did not recur.However, since >600 report had already been reported, blood samples was withdrawn and sent to the laboratory for confirmation, data was 55 mg/dl.The nurse then provided the original vial of test strips to the laboratory, but when tested qc using the lab's glucometer, the result could not produce and showed error (bad sample or replace strip).The laboratory reported that a few days earlier, another unit had also encountered >600 readings during qc checks with a different vial from the same batch, and had discarded that vial.".
Additional Manufacturer Narrative
Retained nova statstrip glucose test strips (lot # 0324120309) were used for the complaint investigation.Testing included five (5) levels of nova statstrip glucose linearity solution, and five (5) levels of whole blood specimens collected from consenting adults.Five (5) nova statstrip glucose meters and one (1) returned nova statstrip glucose meter were used for the study.Four (4) measurements were performed on each meter for each sample (24 measurements total).Plasma ysi glucose results were used as reference values for the whole blood specimens.Retained nova statstrip glucose test strips (lot # 0324120309) meet the performance acceptance criteria for linearity solutions and 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 # 0324120309).After investigation into the one vial of returned nova statstrip glucose test strips (lot # 0324120309) seemed to indicate that the vial had been exposed to moisture, thereby giving the erroneous results seen; indicating an issue with that particular vial of strips but not with the whole strip lot or the reported meter.The vial weight of the returned vial was 17.1980g and the weight of an unused retain vial was 16.178g.This supports that theory that the returned vial was exposed to moisture at some point.Dhr reviews were performed on the reported meter and strip lot.No abnormalities or concerns were observed.The dhr's indicated the released product met all specifications.No further action is recommended at this time.Nova will continue to monitor for this or similar events.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR PATIENT TESTING
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 165 lexington rd; billerica 01821
• Manufacturer Contact: patrick sinclair ; 39 manning rd; billerica, MA 01821 ; 9784393676
• MDR Report Key: 22046922
• Report Number: 1219029-2025-00009
• Device Sequence Number: 18338372
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K150281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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 Model Number: 1.86
• Device Catalogue Number: 54790
• Device Lot Number: 0324120309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female