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

Model Number	712002
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records were reviewed and no anomalies were detected.Actual product was not returned for testing.Retention samples of the same lot of test strips involved in the incident were tested and performed to specification.
Event or Problem Description
Caller stated he is receiving very high readings.Customer stated the first couple weeks the results were normal.The past week and a half he has been receiving high readings in the 240-320 range.Caller stated he mis-dosed due to a meter result of 392 on (b)(6) 2017 at 1:32 pm.Because of the reading, he took his rapid acting insulin (humalog) and his long-lasting insulin (lantus).He started having symptoms right away.The ambulance/paramedics were called and they arrived around 2:00 pm, where they administered a glucose push and transported him to the er where they administered a glucose drip.Once treatment was completed, call was released.Caller believes the reading in question was inaccurate.Customer only has one test strip left from this lot of strips.I asked him to send it back to us.Caller is insulin dependent.Caller is on oxygen therapy.Caller is on numerous medications due to multiple health issues.Caller's testing technique is correct.Controls were used and results were within range.

• Brand Name: RELION CONFIRM BLOOD GLUCOSE TEST 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: 7213493
• Report Number: 1832816-2018-00001
• Device Sequence Number: 869077
• Product Code: NBW
• UDI-Device Identifier: 00605388860163
• UDI-Public: (01)00605388860163
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K124021
• 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): 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Model Number: 712002
• Device Catalogue Number: 712002
• Device Lot Number: E175D25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 85