MAUDE Adverse Event Report: Nova Biomedical Corp. StatStrip; Glucose monitoring system IVD, point-of-care

Model Number	2.0
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2026
Type of Reportable Event	Death
Event or Problem Description
Glucose test performed on 3 different meters and different vials of strips.All gave "bad sample" error.
Additional Manufacturer Narrative
Meter serial number (b)(6) was initially included in mdr 1219029-2026-00039 for this incident, along with two other meters.To maintain device-specific documentation and tracking, separate mdrs have been initiated for the affected meters.A review of the device history record (dhr) for meter serial number (b)(6) was conducted, and no findings related to the reported event were identified.Follow-up attempts were made to obtain additional clinical information from the initial reporter; however, no response has been received to date.The complaint remains under formal investigation.A supplemental report will be submitted upon completion of the investigation, as appropriate.Nova will continue to monitor for this and similar events and will evaluate any additional information received for potential impact on the ongoing investigation.

• Brand Name: StatStrip
• Common Device Name: Glucose monitoring system IVD, point-of-care
• Manufacturer (Section D): Nova Biomedical Corp.; 200 prospect st.; waltham MA 02454
• Manufacturer (Section G): NovaBiomedical Corporation; 165 lexington rd.; billerica MA 01821
• Manufacturer Contact: lyra rem ; 39 manning rd.; billerica, MA 01821 ; +1(978)439-3681
• MDR Report Key: 50525609
• Report Number: 1219029-2026-00046
• Device Sequence Number: 21289164
• Product Code: PZI
• UDI-Device Identifier: 00385480636858
• UDI-Public: (01)00385480636858(11)251110
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K232075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 2.0
• Device Catalogue Number: 63685
• Device Lot Number: 0325342249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown