MAUDE Adverse Event Report: I-SENS, INC. ASSURE PRISM MULTI 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	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The result of control solution test, with returned meter and normal strip, was 88mg/dl(n: 113~169mg/dl) which was lower than standard range.As a result of continuity test, it has been confirmed that the returned meter functioned properly and there were no particular issues found when the returned meter was disassembled.After assembling the returned meter again, the results of control solution test with returned meter and normal strips were within standard range.As reviewing the memory, the returned meter displayed blood glucose measured values normally when using it first time but the low blood glucose measured values started to display during use.Thus, it is assumed that the returned meter functioned properly again after the blood/foreign substance was removed/displaced while disassembling a meter and assembling it again.
Event or Problem Description
Caller received a reading of 96mg/dl (which was out of range) on this one using same strips and control solution.Customer was uncooperative with troubleshooting.

• Brand Name: ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING 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
• MDR Report Key: 11715030
• Report Number: 3005621222-2021-00006
• Device Sequence Number: 3591789
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/23/2021

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: 04/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1