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	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
I-sens analyzed the cause of the low readings based on the returned meter and strip (25t) and control solution.First, we tested the returned meter, strip, and control solution and found that the readings were within the normal range.Based on the analysis results of past cases where an incorrect reading problem temporarily occurred and was resolved, it was estimated that there was something abnormal in the meter connector.As a result, blood inflow in the connector was confirmed.In addition, as a result of comparing the appearance of the strips and the retained strips to check for any strip normalities, there were no unusual features that could cause a measurement value problem.Therefore, it is assumed that the measurement value problem temporarily occurred due to the blood flowing into the connector.However, the foreign blood substances are moved and removed during the repeated insertion and removal of the strip and now operating normally.
Event or Problem Description
Customer reported issues of solution out of range.Complaint was reviewed for investigation and reportability on (b)(6) 2022.Complaint was marked for investigation and determined not reportable per arkray's per internal procedures.On (b)(6) 2022, returned strips failed testing by generating low results out of specification.The strips gave low readings, making this complaint reportable to the manufacturer as a malfunction.(b)(6) 2022 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: 13866812
• Report Number: 3005621222-2022-00002
• Device Sequence Number: 11928624
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/22/2022

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 Expiration Date: 04/12/2022
• Device Model Number: GM505RA
• Device Catalogue Number: 530001
• Device Lot Number: SM13MAE2B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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