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

Model Number	701103
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records were reviewed, and no anomalies were detected.Meter involved in incident was returned for evaluation.Meter was evaluated with retain strips of specified lot and performed to specification.No failure detected.
Event or Problem Description
Patient has owned the meter for one week.Patient stated that he was mistreating himself throughout the day based on the high readings the meter provided.On (b)(6) 2020, patient took three readings throughout the day and treated himself based on the readings as follows; 9:49 am - 532 reading - 10 units of insulin; 1:38 pm - 331 reading - 7 units of insulin; 7:52 pm - 431 reading - 7 units of insulin.Patient then felt symptoms but couldn't tell if he was feeling hyperglycemic or hypoglycemic because he sometimes feels the same way for both and felt that his blood sugar was not under control.Patient also has epilepsy and was experiencing "auras" during this time which indicate a possible seizure may be oncoming.Because he felt his blood glucose was not under control and he was worried about having a seizure, he went to the emergency room.While patient was at the emergency room, he was tested with the relion prime meter and received a result of 402, and when the hospital tested his blood glucose with their equipment, they received a reading of 80, indicating that he was hypoglycemic.The patient was treated with a saline iv and his blood sugar was tested periodically, and he was also given food to help with the low blood glucose he was experiencing.Patient does not want a replacement device and is going to use his one touch meter.Sent return label.

• Brand Name: RELION PRIME BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ARKRAY FACTORY, INC.; 1480 koji konan-cho; koka shiga, 520-3306, ; JA
• MDR Report Key: 9873378
• Report Number: 1832816-2020-00009
• Device Sequence Number: 2877827
• Product Code: NBW
• UDI-Device Identifier: 00681131130332
• UDI-Public: (01)00605388022936,(01)00681131130332
• Combination Product (Y/N): N
• 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): 02/27/2020

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: 07/25/2021
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 011420A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/24/2020
• 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; Life Threatening; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 73