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

Model Number	701103
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2017
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 is reporting high blood readings.Date of the incident was (b)(6) 2017.She tried calling two times yesterday (5/23/2017) but she was on hold for 30 minutes each time.Caller received a reading of 392 and became alarmed, so she called her doctor, and her doctor told her to call 911 and get to the hospital.Caller was having symptoms of dizziness, shaky, she had very bad headache, and her stomach was queasy.She did not feel these symptoms matched the reading she received.When the paramedics came, the received a reading of 90.She did not take any medication at the time of the incident.Earlier in the day she had eaten and taken her normal dose of 18 units of insulin.When she got to the hospital, her blood glucose was 90.At the hospital, she was diagnosed with a bladder and kidney infection.There have not been any changes in her diet, exercise, medications, or stress.She is not undergoing oxygen therapy.She washes and dries her hands with soap and water.She pokes on the fingertip and uses a new lancet each time.She usually doesn't have problems getting a blood sample, only when her readings are low she has a harder time.She holds the meter and test strip straight out and lets the blood draw into the meter.Test strips have been opened for a week and she stores the meter and test strips together in her chair in the living room.The supplies that she does not use are in the dresser.Products have not been exposed to extreme temperatures.The meter appears to be in good condition.Controls were not used as caller does not have control solution.
Additional Manufacturer Narrative
Meter and test strips involved in incident were returned and evaluated and performed to specification.Retain strips were also tested with returned meter and performed to specification.No failure detected.

• 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: 6670258
• Report Number: 1832816-2017-00008
• Device Sequence Number: 1541330
• Product Code: NBW
• UDI-Device Identifier: 00605388022936
• UDI-Public: 00605388022936
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 05/24/2017

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: 08/31/2018
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 030117B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 08/14/2017
• 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
• Patient Age: 72 YR
• Patient Weight: 112