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

Model Number	GM505RA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
As the complaint meter was returned, i-sens conducted control solution and blood tests using the complaint meter and reference strips.Firstly, as a result of the control solution test, all results satisfied the acceptable range in both a and b levels.Secondly, the test was conducted using capillary blood with a concentration similar to the customer's blood glucose level at the time of the issue, and it resulted in "hi" (occurring when the glucose level is above 600mg/dl) for all 10 tests.Therefore, it is confirmed that the meter is operating normally.The following is a partial excerpt from the assure prism multi user manual, regarding its limitations: "inaccurate results may occur in severely hypotensive (having low blood pressure) individuals or patients in shock.Inaccurate low results may occur for individuals experiencing a hyperglycemic hyperosmolar state, with or without ketosis.Critically ill patients should not be tested with the assure? prism multi blood glucose monitoring system." based on the reported customer's blood glucose level, it is inferred that the customer may be experiencing a hyperglycemic hyperosmolar state.In such cases, assure prism may produce inaccurate measurement values as stated in the user manual.

• Brand Name: ASSURE PRISM 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: 16959392
• Report Number: 3005621222-2023-00005
• Device Sequence Number: 5238211
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/16/2023

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: GM505RA
• Device Catalogue Number: 530001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• 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: Other; Hospitalization
• Patient Sex: Unknown