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	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history records were reviewed and no anomalies were detected.Meter and strips involved in incident were returned.Meter, returned strips, and retain strips were evaluated and performed to specification.No failure detected.
Event or Problem Description
Caller stated that she is getting high readings.Caller's normal reading range is 130-140.Caller stated that she had to visit the hospital because of the readings from this meter.Yesterday, (b)(6) 2017, she received a reading of 472 and had symptoms and called her doctor who advised her to call 911.The ambulance came five minutes later and they received a reading of 132 on their meter.When she got to the hospital, they received a reading of 89.When asked if she was treated with anything at the hospital, the caller stated that they did no treatment at all.Caller also noted that she was diagnosed with vertigo when she went to the hospital.When asked if the symptoms she felt matched low or high blood sugar, caller stated that generally she feels the same way whether she's high or low.Caller washes and dries hands before testing, and also uses alcohol.She is testing from the fingertip and uses a sterile lancet before testing.Caller sometimes has issues getting a blood sample.Testing technique is correct.Customer reported that she did a control solution test on (b)(6) 2017, and received a result of 106, which was out of range as the range on her strip bottle is 83-103.Since then, customer has lost her control solution and cannot find it, so another control solution test could not be done.

• 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: 6587042
• Report Number: 1832816-2017-00005
• Device Sequence Number: 11082452
• Product Code: NBW
• UDI-Device Identifier: 00605388022936
• UDI-Public: 00605388022936
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

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: 030917A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 05/24/2017
• 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: 39 YR
• Patient Weight: 78