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

Model Number	701102
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2016
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 returned and evaluated and performed to specification.No failure detected.
Event or Problem Description
Caller indicated relion prime meter was giving high blood readings.Meter is less than one week old.Because of high readings she went into the er yesterday.Yesterday at 6:30 am before she ate, she took a reading and received 478.She did not take insulin but called her doctor to report the high reading and was told to go to the er.She was taken by ambulance.A reading was taken in the ambulance and it was 100 something but she does not know the exact reading.Inktel stated that the reading was 150.The comparison of 478 and 150 is a 68.6% variance and is in zone c.No treatment was given because her blood glucose level was good.Caller did state that she had another medical issue not related to her blood glucose variance that she was treated for at the hospital.Normal readings before eating are 117.Lantus and metformin are the medications she takes.No changes to diet, exercise, stress.She cleans the test site (finger) with alcohol and changes the lancet every time.She has no trouble getting a blood sample and performs the test correctly.Caller is insulin dependent.Please expedite shipping of meter, strips, cs and send rl.Controls not used.

• 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 601-89045, ; JA
• MDR Report Key: 6151766
• Report Number: 1832816-2016-00018
• Device Sequence Number: 13533982
• Product Code: NBW
• UDI-Device Identifier: 00605388022929
• UDI-Public: 00605388022929
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/12/2016

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: 03/31/2018
• Device Model Number: 701102
• Device Catalogue Number: 701102
• Device Lot Number: 081616A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2016
• Initial Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 133