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 Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint products were returned, i-sens analyzed the cause of the low readings using the returned meter, strips, and control solution.As a result of the control solution test, all results were within the standard range, and the cv% was within the acceptance criteria (below 5%) which satisfied the internal standard in i-sens.Therefore, it is judged that the product operated normally.
Event or Problem Description
Meter was purchased and placed into service in (b)(6) 2022.Caller stated they were called on (b)(6) 2022 regarding a patient with diabetic issues.When ems arrived, patient was nearly unconscious.The patient's mother stated that she did not know what led to the patient being in this state and did not know if he had eaten or taken insulin.Caller reported that they did a test with the prism and received a reading of 240.They then started iv therapy to treat patient for possible diabetic ketoacidosis (dka) due to patient's history and signs/symptoms, but the blood glucose readings didn't support the diagnosis.Caller stated they then performed another test with the prism and received a reading of 460.Patient was then transported to the hospital (b)(6) where they tested patient with the nova statstrip glucometer, and they received two consecutive "high" readings.The hospital then tested venous blood and received a glucose level reading of 770.Patient was then treated by the hospital, but the course of their treatment is unknown.Caller stated this was the first time using this device and is concerned that it is not accurate.Replaced meter, strips and sent return label.

• 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: 15876053
• Report Number: 3005621222-2022-00022
• Device Sequence Number: 16767286
• Product Code: NBW
• UDI-Device Identifier: 00015482500504
• UDI-Public: (01)00015482530013,(01)00015482500504
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083468
• 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): 11/29/2022

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: 04/22/2024
• Device Model Number: GM505RA
• Device Catalogue Number: 530001
• Device Lot Number: UM25MAAHB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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: Hospitalization; Other
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 45 KG