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

Model Number	530001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per exemption number e2016001.Meter and test strips involved in complaint were returned and evaluated.Meter was tested with a combination of strip and control solution lots.Returned meter failed both control solution and blood testing, reading lower than specification, confirming the complaint.The same lots of strips and controls passed testing on a control meter, demonstrating this is a meter issue.Product will be shipped to the manufacturer for root cause analysis.
Event or Problem Description
Caller said that meter is reading low with the level 2 control solution.Tried to do a control solution test, but it would not give a reading.Items are kept together in pouch.The pouches are stored on the truck in a neutral temperature area.Replaced meter, strips, cs, and sent return label.
Additional Manufacturer Narrative
Manufacturer's investigation report received was received 5/25/2018.The result of control solution test, with returned meter and a normal strip, was 91 mg/dl, which was out of standard range (109-163 mg/dl).As a result of disassembling meter, it was discovered that a liquid substance had flowed into the connector.Improper use.

• Brand Name: ASSURE PRISM BLOOD GLUCOSE SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): I-SENS, INC.; 43, banpo-daero 28-gil; seocho-gu; seoul 06646, ; KS
• MDR Report Key: 7453636
• Report Number: 3005621222-2018-00002
• Device Sequence Number: 16521532
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Emergency Medical Technician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: Emergency Medical Technician
• Device Expiration Date: 09/06/2019
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: PT07MAC4H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2018
• Device Age: 2 YR
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1