MAUDE Adverse Event Report: I-SENS ASSURE PRISM MULTI BLOOD GLUCOSE TEST SYSTEM; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505RA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Chest Pain (1776); Hyperglycemia (1905)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint meter was returned, i-sens conducted control solution tests with the returned meter and complaint lot retained strips.All results were within the allowable range wirh 153, 160, 156, 159, 160 mg/dl (a: 112-167 mg/dl), and 235, 252, 239, 231, 250 (b: 189-283 mg/dl).Additionally, as a result of disassembling the meter, there were no abnormalities such as inflow of blood or foreign substance or pin deformations found within the connectors, therefore, it is determined that the meter is functioning normally.
Event or Problem Description
On (b)(6), 2023, franklin community fire department received a call for chest pains.Upon arrival, patient was conscious, and she was exhibiting signs of low blood glucose.The fire department did a blood glucose test with the assure prism meter and received a reading of 31.Fire department personnel had her eat a peanut butter and jelly sandwich and drink some sweet tea.They checked her blood glucose again 10 minutes later with the assure prism meter and the reading was 32, which seemed unusual.The ems crew arrived to take over the situation, and when they tested the patient's blood glucose with their meter, the reading was 480.The fire department left, and ems personnel transported patient to the hospital where it is unknown what kind of treatment she received.When caller returned to the fire department after the call, the caller performed a blood glucose test on himself with the assure prism and received a reading of 41.Caller performed a control solution test with the assure prism using l2 control solution and received a reading of 31 and the range for the l2 control solution was 31, indicating the meter was still reading low, even with control solution.The same control solution was used to test other assure prism meters that the caller had, and those test results were within range.Replaced meter, strips and sent return label.

• Brand Name: ASSURE PRISM MULTI BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• Manufacturer (Section G): I-SENS WONJU FACTORY; 94-1, donghwagongdan-ro; munmak-eup; wonju-si, 26365 ; KS 26365
• Manufacturer Contact: hyojin baik ; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 17359001
• Report Number: 3005621222-2023-00012
• Device Sequence Number: 15083914
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

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: 08/05/2024
• Device Model Number: GM505RA
• Device Catalogue Number: 530001
• Device Lot Number: UL06MAD3A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 109 KG