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

Model Number	GM505RA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
I-sens conducted a cause analysis of the reported problem with the returned meter.When testing the control solution with the returned meter and normal strips 10 times, the meter detected the strip insertion all 10 times but did not detect the application of the solution 7 times.Also, the lo message occurred in the remaining 3 times where the measurement was performed.As a result of disassembling the meter, it was confirmed that foreign substances had flowed into the connector.
Event or Problem Description
Customer reported issues of does not register solution/blood.Complaint was reviewed for investigation and reportability on 11/15/2021.Complaint was marked for investigation and determined not reportable per arkray's per internal procedures.On december 16, 2021 returned meter, failed testing by generating low results, out of specification.The meter gave low readings, making this complaint reportable to the manufacturer as a malfunction.December 16, 2021, marks the aware date for mdr filing.

• Brand Name: ASSURE PRISM MULTI BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS, INC.; 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: hee seon ; 43, banpo-daero, 28-gil; seocho-gu; seoul, 06646
• MDR Report Key: 13691917
• Report Number: 3005621222-2022-00001
• Device Sequence Number: 1943684
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown