MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; BLOOD GLUOSE METER

Model Number	56222
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint could not be confirmed or reproduced.The hospital confirmed that qc and linearity results were all within the manufacturer's range.The hospital also confirmed the patient's compromised circulation.Retained nova statstrip glucose test strips all met performance acceptance criteria when tested with linearity solution as well as with blood.Per the ifu, caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capilllary specimen collection.A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow.The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient's condition is rapidly changing.If a capillary whole blood glucose result is not consistent with a patient's clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the statstrip glucose hospital meter system.No root cause was identified as the complaint was not able to be reproduced.A potential root cause is that the patient might not have been a good candidate for fingerstick (capillary) testing due to poor circulation.A dhr review was performed.No abnormalities or concerns were observed.The dhr 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.
Event or Problem Description
69 year old male in critical care was given 2 amps of dextrose based on capillary glucose results obtained on the statstrip glucose hospital meter system.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: BLOOD GLUOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02545 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02545 9141
• Manufacturer Contact: patrick sinclair ; 200 prospect st; waltham, MA 02545-9141 ; 7818940800
• MDR Report Key: 16420057
• Report Number: 1219029-2023-00001
• Device Sequence Number: 15049235
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

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: 11/21/2024
• Device Model Number: 56222
• Device Catalogue Number: 54790
• Device Lot Number: 0322325249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2021
• 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 Age: 69 YR
• Patient Sex: Male