MAUDE Adverse Event Report: ARKRAY, INC. GLUCOCARD VITAL BLOOD GLUCOSE TEST SYSTEM

Model Number	761100
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Patient did a test on saturday, (b)(6) 2018 in the morning while fasting.He received a reading of 41.He didn't think the reading was accurate and tested again right away.He used a different finger and received 219, then 203, all within 10 minutes.This is a new meter that is about 2-3 weeks old.Strips were opened 2-3 weeks ago.Patient stores products in his bedroom.Patient is not receiving any oxygen therapy.Doesn't have trouble getting a sample of blood.Uses alcohol wipes and allows fingers to dry thoroughly, uses fingertip as a testing site.Seals the bottle cap tightly and immediately after removing a test strip.Changes lancets every time he tests.Customer's wife stated that he did not have any symptoms associated with the readings.He did not take any medication.He did not contact the paramedics or go to the er.His normal glucose readings are unknown.He takes humulin for diabetes.He has improved on his diet by cutting back carbs and measuring food portions.No physical damage to the meter or debris around the test strip port.The meter looks brand new.He tested again today and received a reading of lo, then he tested again and received 204 while fasting.He did not take any medication based on the readings.He wasn't comfortable with taking any medication.He did not perform a control solution test.Replaced meter, test strips, sent control solution, and return label.(b)(4).

• Brand Name: GLUCOCARD VITAL 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: 7322972
• Report Number: 1832816-2018-00004
• Device Sequence Number: 13482587
• Product Code: NBW
• UDI-Device Identifier: 00015482760014
• UDI-Public: (01)00015482760014
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/12/2018

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: 03/16/2019
• Device Model Number: 761100
• Device Catalogue Number: 761100
• Device Lot Number: 080917D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 100