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

Model Number	701103
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter and test strips involved in incident were returned and evaluated.Eight returned test strips failed blood testing, and all read lower than specification.Complaint confirmed.Retain test strips passed testing with no failures detected.Iscar 37 has been issued to have meter and test strips further investigated by manufacturer.
Event or Problem Description
Caller testing within half hour.Changes lancets every time.Stores meter in kitchen on table.Received 153 on ultima and 88 on prime and that was within a few minutes apart.Caller doesn't trust meter at all.Comparison is 42.484% variance and the was in zone b.Sending out rl to customer.She does not want prime meter again but is wondering if our company can send out ultima.I informed her that we deal with the prime, confirm and micro meters and not the ultima, but i can request and see, and if not have someone call her.Please call her if unable.Sent her rl.

• 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: 6604954
• Report Number: 1832816-2017-00006
• Device Sequence Number: 18989702
• Product Code: NBW
• UDI-Device Identifier: 00605388022929
• UDI-Public: 00605388022929
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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: 07/31/2018
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 020217A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1