MAUDE Adverse Event Report: I-SENS ASSURE® PRISM MULTI BLOOD GLUCOSE METER; PORTABLE BLOOD GLUCOSE METER

Model Number	530001
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Altered State of Consciousness (4589)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the accuracy issue with a reference meter and retained strips from the complaint lot.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 with blood whose glucose concentration was adjusted to be similar to 54 mg/dl, estimated to be the patient's blood glucose level at the time of the incident.As a result, all readings fall into the acceptance criteria.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
Caller stated they received the meter two months ago.Caller stated the meter and strips are stored on the ambulance.Caller stated they were called for an unresponsive patient.They tested the meter twice with the patient and received blood glucose readings of 219 ((b)(6) 2024 at 8:09 pm) and 212 (b)(6) 2024 at 8:08 pm).The patient was not treated by the ambulance personnel based on the readings they received.The ambulance crew activated stroke protocol.They transported the patient to the emergency room and the emergency room tested the patient's blood glucose with their meter and registered their blood glucose at 54.The caller stated this meter is reading too high based on the readings received with this meter and the reading that was received at the emergency room.The emergency room further treated the patient with activated stroke protocol and medications, but their complete course of treatment is unknown.Replaced meter, strips, sent control solution and sent return label.
Additional Manufacturer Narrative
Before the defective product was recalled, a control solution test was conducted using a reference meter and retained strips, and all the results satisfied the acceptable range.As the complaint products were returned, i-sens conducted clinical tests using three types of capillary blood, adjusting the concentration into low, medium, and high levels.As a result, all readings satisfied 15 mg/dl or % compared to the standard equipment, and sd and cv also satisfied the acceptable range.Therefore, we confirmed that the product is functioning properly.Additionally, in this follow-up report, we have also made updates regarding udi-related data quality.
Event or Problem Description
Caller stated they received the meter two months ago.Caller stated the meter and strips are stored on the ambulance.Caller stated they were called for an unresponsive patient.They tested the meter twice with the patient and received blood glucose readings of 219 ((b)(6) 2024 at 8:09 pm) and 212 ((b)(6) 2024 at 8:08 pm).The patient was not treated by the ambulance personnel based on the readings they received.The ambulance crew activated stroke protocol.They transported the patient to the emergency room and the emergency room tested the patient's blood glucose with their meter and registered their blood glucose at 54.The caller stated this meter is reading too high based on the readings received with this meter and the reading that was received at the emergency room.The emergency room further treated the patient with activated stroke protocol and medications, but their complete course of treatment is unknown.Replaced meter, strips, sent control solution and sent return label.

• Brand Name: ASSURE® PRISM MULTI BLOOD GLUCOSE METER
• Common Device Name: PORTABLE BLOOD GLUCOSE METER
• 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: 20061887
• Report Number: 3005621222-2024-00010
• Device Sequence Number: 7728658
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 11/22/2025
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: WN01MAPLB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 156 KG