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

Model Number	701102
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter and test strips involved in incident were returned and evaluated.Six returned test strips failed blood testing, and all read lower than specification.Complaint confirmed.Returned meter and retain test strips passed testing with no failures detected.Action request 170 issued to have meter and test strips further investigated by manufacturer.
Event or Problem Description
Customer called in stating that her readings have been lower than normal lately.She's had the meter for about a year and the test strips are prime and were just recently opened about 2-3 weeks ago.Customer is a registered nurse and was testing on herself.She is not a diagnosed diabetic and is not treating with any medication but is a prediabetic and wanted baseline results.Strips were purchased at different times.She notes that she realized the results were low but she felt fine so did not act immediately.She mentioned this to her md and they provided her with a freestyle.She noted that the freestyle was giving results that were nearly 40 points higher than her prime.Strips are stored in a pantry; cool and dry with no heat or humidity.Strips are removed one at a time and bottle is re-sealed immediately.We went over proper testing techinques and she seemed to be following all the correct steps.I then offered her to do a test with cs but she did not have any so i offered to get some sent out to her.She then stated that she doesn't think it's the strips.She said she has bought a few different bottles and they continue to roughly all read lower than what she should be at.She was pretty sure there was an issue with her meter so i offered to get the meter replaced for her and also have cs and rl sent to her.Controls not used.

• Brand Name: RELION PRIME BLOOD GLUCOSE SYSTEM
• Common Device Name: RELION PRIME BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): ARKRAY, INC.; 57 nishiaketa-cho; higashi-kujo, minami-ku; kyoto 601-8045, ; JA
• MDR Report Key: 6559678
• Report Number: 1832816-2017-00004
• Device Sequence Number: 97992
• Product Code: NBW
• UDI-Device Identifier: 00605388022929
• UDI-Public: 00605388022929
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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: 05/31/2018
• Device Model Number: 701102
• Device Catalogue Number: 701102
• Device Lot Number: 102716A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1