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

Model Number	761100
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/28/2018
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
Customer took a reading yesterday evening around 6 pm and received lo, then four minutes later he took another test and received 474.He didn't trust the reading, so he called the ambulance.The ambulance arrived and took his blood sugar and they received 344.While he was inside the ambulance, they attempted to administrate an iv but was unsuccessful.After he arrived at the hospital they were able to connect him to an iv.The iv wasn't bringing his glucose down fast enough so they treated him with five units of fast acting insulin.They checked his blood sugar again and noticed it wasn't decreasing and treated him with a second round of five units of fast acting insulin.The last treatment brought his reading down to about 274mg.Then they were able to discharge him.Verified the customer has had the meter for one year.Customer opened test strips about four days ago.He is not receiving any oxygen therapy.Caller doesn't have trouble getting a sample of blood.Stores both his meter and test strips in the living room.Verified he seals the test strips immediately and tightly after removing a test strip.He washes his hands with soap and water and dries them thoroughly.He uses his fingertip as a testing site and sometimes changes his lancets.He did not perform a control solution test.Customer stated that he can't remember if he had symptoms.Customer has type 2 diabetes.He takes lantus, apidra, metformin, januvia, and glipizide for his diabetes.Customer has not had any changes in his diet, exercise, medication or stress levels.
Additional Manufacturer Narrative
Device history records were reviewed and no anomalies were detected.Meter involved in incident was returned.Meter was evaluated with retain strips and performed to specification.No failure detected.

• Brand Name: GLUCOCARD VITAL BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): ARKRAY FACTORY, INC.; 1480 koji konan-cho; koka shiga, 520-3306, ; JA
• MDR Report Key: 7905565
• Report Number: 1832816-2018-00020
• Device Sequence Number: 13873940
• Product Code: NBW
• UDI-Device Identifier: 00015482760502
• UDI-Public: (01)00015482760014,(01)00015482760502
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/12/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/08/2019
• Device Model Number: 761100
• Device Catalogue Number: 761100
• Device Lot Number: 012618C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 120