MAUDE Adverse Event Report: I-SENS, INC. ASSURE PRISM BLOOD GLUCOSE TEST SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	530001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product involved with incident was returned for evaluation product involved with incident was returned for evaluation to (b)(4) (importer and complaint handler).Meter was tested with returned strip lot qs06maw9p, expiration 2020-10-05 and performed to specification.No failures detected.Complaint unconfirmed.(b)(4).
Event or Problem Description
We received an email report from bound tree from this facility stating, "glucometer malfunctioning, reading too high, may need to be calibrated." attempted to contact customer but he will not be in until next thursday.I spoke with the fire chief but she wasn't aware of the situation at all, so she took down the information and said that she will have him contact me.Customer did call back and about a week ago, they had a call where there was a diabetic emergency and our meter read somewhere in the 200's but he doesn't know for sure because he wasn't there.Then they used a different brand meter and received a reading in the 50's and a third meter and that one was in the 40-50 range also.They tested this meter with someone at the station with this meter and received the same results.Caller doesn't know about how tests were performed, cleaning or specifics as far as what was done.They have never performed control tests on any of their meters, so i am sending some.He just said the person was taken to the hospital.Replaced meter system and sent return label for customer to return product.

• Brand Name: ASSURE PRISM BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): I-SENS, INC.; 43, banpo-daero 28-gil; seocho-gu; seoul 06646, ; KS
• MDR Report Key: 8989330
• Report Number: 1832816-2019-00018
• Device Sequence Number: 365867
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2019
• Report Date (Section F): 09/11/2019

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 Model Number: 530001
• Device Catalogue Number: 530001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2019
• Date Report to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Date Report Sent to FDA: 09/11/2019