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

Model Number	701103
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history records were reviewed and no anomalies were detected.Meter and test strips involved in incident were not returned by the customer.Retain strips and qs meter were evaluated and performed to specification.No failure detected.
Event or Problem Description
Caller indicated the relion prime meter was giving variable readings.Contacted customer to gather more information.Customer stated he received a reading of hi and lo in about 10 minutes.He was upset about not receiving the order for control solution.He was also upset that it did not arrive with the other replacement meter that was shipped back on (b)(6) 2017.I searched the history and saw we received the control solution request through relion.Com.I explained the process how it works when he calls in to request the solution and that the request were separate.He then proceeded to explain his disliking for the meter.I apologized and explained that because of the reading hi and lo within a 10 minute time frame that i would need to complete an incident report.He continued to ask me why? what for? i tried again to explain because we have to report details to the fda and our replacement process.He refused to give me any information or answer any of my questions.He stated that the questions are too personal and that it's his important information.I will complete the incident report with the details that i have.The customer is very uncooperative and unwilling to answer the questions from the incident report.He stated i don't know and "unknown" to my questions.However, customer is willing to accept replacement meter with replacement bottle of test strips and control solution.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: 6507268
• Report Number: 1832816-2017-00002
• Device Sequence Number: 1330799
• 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): 03/24/2017

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: 07/31/2018
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 021317C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR