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

Model Number	701103
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	10/07/2017
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 with low readings confirming the complaint.Returned test strips also produced two e 13 complaints.Retain test strips passed testing with no failures detected.Action request 203 (iscar 50) issued to have meter and test strips further investigated by manufacturer.
Event or Problem Description
Caller stated meter is giving inaccurate readings.Caller received a reading of 72 and stated that is too low and she often gets lower readings than that.Caller didn't want cs, just wanted refund.Caller purchased meter on august 25, 2017.Caller purchased strips in august as well.She went to doctor on (b)(6) and received 267, and received 183 at lab.Caller doesn't trust this meter and is going to buy another meter and strips because she will be in the hospital for two months and needs it now with her refund.She does want cs, but wants to send this meter and strips back.Sent customer a return label to send products back.

• 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: 7032880
• Report Number: 1832816-2017-00011
• Device Sequence Number: 13805622
• Product Code: NBW
• UDI-Device Identifier: 00605388022936
• UDI-Public: 00605388022936
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/09/2017

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: 02/28/2019
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 072817B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1