MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; BLOOD GLUCOSE MONITOR FOR NEAR-PATIENT TESTING

Catalog Number	54790
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Hyperglycemia (1905); Peripheral Edema (4578)
Date of Event	08/21/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
(e1) the name of the initial reporter was not provided.Patient was given doses of vitagen (glucose) based on meter results.Patient aministerd vasopressor pitressin and adrenaline while in the er.Capillary sample testing is contraindicated for patients with compromised capillary blood flow.All samples tested on the statstrip glucose hospital meter system were capillary samples.Instruction for use manual: caution: capillary blood glucose testing may not be appropriate for persons with decreased peripheral blood flow, as it may not reflect the true physiological state.Examples include, but are not limited to, sever hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration.Information provided by the hospital indicates the patient condition was 'bad' when sent to the hospital."the doctor thinks the patient passed away not necessarily related to the glucose treatment".The customer complaint could not be confirmed nor replicated.The meter and test strips in question were not returned for evaluation.This is further supported by the confirmation from the hospital that the meter and glucose test strips passed all qc prior to and after the reported incident.The meter system remained in service at the facility.Retained statstrip test strips from the reported lot were test met the performance acceptance criteria for linearity controls and also for whole blood specimens.No discrepant results were observed.A dhr review was performed for the identfied meter and glucose strip lot.No abnormalities or concerns were observed.The dhr indicated the released product met all specifications.No further action is recommended at this time.Nova biomedical will continue to monitor for this or similar events.
Event or Problem Description
"the patient glucose tested as 12 mg/dl at 11:33.After giving the vitagen (glucose), a venous sample was drawn and run on the clinical analyzer.The result was tested as 881 mg/dl on clinical analyzer (11:59-12:32).While the results still keeps low as 13 mg/dl on statstrip glucose (test time: 12:14).The meter reports differently comparing to the lab system.".

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITOR FOR NEAR-PATIENT TESTING
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer Contact: rebecca figueira ; 39 manning rd; billerica, MA 01821 ; 9784393638
• MDR Report Key: 17980167
• Report Number: 1219029-2023-00002
• Device Sequence Number: 3430173
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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 Expiration Date: 10/04/2024
• Device Catalogue Number: 54790
• Device Lot Number: 0322094309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown