MAUDE Adverse Event Report: I-SENS, INC. ASSURE PRISM BLOOD GLUCOSE TEST SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	530001
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2023, meter involved in incident was returned for investigation.During initial diagnostic testing, it was noted that the print was rubbed off on label and there was a white foreign material under the lcd screen cover.Customer did not return or report a strip lot, so on (b)(6) 2023, reference strip lot uu10machc, expiration 2024-07-09 was tested with the returned meter.Meter and reference strips passed blood testing with no failures detected.Meter will be returned to the manufacturer for further investigation.
Event or Problem Description
Customer originally called on (b)(6) 2023, however, they needed to gather more information, and the majority of the information received was on(b)(6) 2023, so the complaint was logged that day, but the aware date of the issue was (b)(6) 2023.Ems went to a call, and they received a reading of 297, but when they transported the patient to the hospital, the reading received was 1,940.Reporter does not know how much time passed between the reading they received and the reading the hospital received.The reporter did not know if treatment was altered due to the reading and she was not sure, but stated probably not, as they normally would have just transported the patient to the hospital.They did a control test after returning to the station and the meter read within range on the cs test.The reporter does not have the test strips or control solution anymore, so the lot information is not available for either the test strips or the control solution.Replaced meter and sent return label.

• Brand Name: ASSURE PRISM BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): I-SENS, INC.; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 16879142
• Report Number: 1832816-2023-00007
• Device Sequence Number: 7290802
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2023
• Report Date (Section F): 05/05/2023

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 Model Number: 530001
• Device Catalogue Number: 530001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/05/2023
• Event Location: Home
• Date Report to Manufacturer: 05/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/05/2023