MAUDE Adverse Event Report: ARKRAY, INC. RELION PRIME BLOOD GLUCOSE SYSTEM; BLOOD GLUCOSE TEST SYSTEM

Model Number	701102
Medical Device Problem Codes	Low Test Results (2458); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter and test strips involved in incident were returned and evaluated.Four returned test strips failed blood testing, and all read lower than specification.Complaint was also confirmed with e 13 error messages.Retain test strips passed testing with no failures detected.Action request 203 issued to have meter and test strips further investigated by manufacturer.
Event or Problem Description
No physical damage to the meter.No debris around the test strip port.Purchased meter back in august.Received new assure dose solution.Caller is getting e 13.Walked customer through a blood test using the assure dose solution, customer gets e 13 error message while holding strip vertical.Customer not receiving oxygen therapy.Stores in office.Changes lancets sometimes.Washes hands with soap and water.Uses fingertip as a testing site.

• Brand Name: RELION PRIME BLOOD GLUCOSE SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): ARKRAY, INC.; 57 nishiaketa-cho; higashi-kujo, minami-ku; kyoto 601-8045, ; JA
• MDR Report Key: 7014835
• Report Number: 1832816-2017-00010
• Device Sequence Number: 19077079
• Product Code: NBW
• UDI-Device Identifier: 00605388022929
• UDI-Public: 00605388022929
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Model Number: 701102
• Device Catalogue Number: 701102
• Device Lot Number: 050817C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1