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	Hypoglycemia (1912)
Date of Event	11/14/2016
Type of Reportable Event	Serious Injury
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.Retain test strips also evaluated and performed to specification.No failure detected.
Event or Problem Description
Caller reporting high blood glucose reading.She has not been diagnosed as diabetic and is not being treated for diabetes.She is pregnant and is dealing with severe hypoglycemia and is being monitored for it.Her blood sugar normally runs pretty low, so she has adjusted her diet to constantly be eating sugar to keep blood glucose levels up.Her blood glucose never usually goes above 140.Caller received a reading of 464.Caller was experiencing symptoms of dizziness and lightheadedness.She panicked and called 911.Firemen and paramedics arrived.Paramedics did back to back readings using their meter and the relion prime.They received a reading of 105 on the paramedic's meter and a reading of 366 on the relion prime.This is a 71.3% variance and in zone c.Paramedics determined that the caller was indeed low, but could not treat her as she's not a diabetic.They monitored her vitals and checked for fetal tones on the baby since the caller deals with hypoglycemia.Caller stated that she didn't eat a stable meal that day and felt this could be why she wasn't feeling well.She was snacking and eating smaller meals throughout the day.She tests every two hours and is constantly monitoring sugars.Caller has recently been under a considerable amount of stress.She just left an abusive relationship situation.Other than that, nothing has really changed in terms of medication/lifestyle.She is trying to eat healthier while maintaining sugar levels.When going through testing technique, it sounds like she is doing things properly and makes sure needles are changed out for every test.Sometimes they are not if she forgets them and is on the road, she will reuse lancets.Advised to make sure to use clean needle on each test taken.When caller applies blood to meter, she usually puts finger up to strip to applying it.Went through how to properly apply blood and hold meter.Meter/strips are a recent purchase and stored in purse/backpack and when she's at shelter she stores in bedroom.She was advised by paramedic team to look into meter issue and go to a (b)(6) pharmacy.Caller went there and pharmacist wasn't able to answer questions, so caller was directed to us for assistance.Controls not used.Please replace meter, 50ct test strips, send control solution and return label.

• 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: 6151776
• Report Number: 1832816-2016-00019
• Device Sequence Number: 323200
• Product Code: NBW
• UDI-Device Identifier: 00605388022929
• UDI-Public: 00605388022929
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/16/2016

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: 03/31/2018
• Device Model Number: 701102
• Device Catalogue Number: 701102
• Device Lot Number: 082216B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 88