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

Model Number	GM505RA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As complaint meter was returned, i-sens conducted a control solution test with the returned meter and retained strips of the complaint lot.The results showed that all results were within the acceptable range, and the cv% satisfied the internal standard in i-sens.Therefore, it is concluded that the product operated correctly.
Event or Problem Description
The caller reported that a meter was reading low.The caller stated that he was not there when the incident happened, but his team was there.The caller stated that when his team used the assure prism on the patient, they received a reading of 221 at 1:44 am on (b)(6) 2023.The caller stated that when they took the patient to the hospital, the lab work on the patient stated their blood glucose was 600.The caller stated that it was 10 to 15 minutes between when they took the patient's blood sugar with the meter and doing lab work on the patient.The caller stated that he does not know what the reading was for the control solution, but the control solution reading was in range.Replaced meter, strips and sent return label.

• Brand Name: ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING 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: 18332360
• Report Number: 3005621222-2023-00014
• Device Sequence Number: 12884088
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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: 03/21/2025
• Device Model Number: GM505RA
• Device Catalogue Number: 530001
• Device Lot Number: WF22MAJUA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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
• Patient Sex: Unknown