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

Model Number	701103
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records were reviewed, and no anomalies were detected.Meter and five test strips involved in incident were returned and tested.Retain strips were tested as well.All blood testing passed with no failures detected.
Event or Problem Description
The meter is five months old and the caller is receiving high readings along with an error code that she is not sure about.No damage or liquid exposure occurred with meter or test strips.Caller received a high reading, over 300.Although caller was not having any symptoms, she was concerned about the high reading and went to the er about one hour after testing.She drove herself to the er.This has never happened with this meter and is the only meter patient has ever used.Caller states the physician received a low reading of 65, that she was hypoglycemic and informed patient that the meter was defective.The hospital staff provided sugared ice chips until readings were within normal range.No further treatment was needed.Caller replaced batteries in march.Caller then stated she received an error code, but it keeps saying it was all eee's.Caller is not sure what error code she received and could not give a definitive answer about which code it was.Informed caller that all products involved in the incident (strips and meter) must be returned immediately.Informed caller that we will replace meter, test strips, and send control solution.Informed caller on how to perform a control solution test.Informed caller on how to exchange the new meter/test strips and for the defective meter/test strips once the package arrives and how to use the return shipping label.Replaced meter, 25ct strips, sent cs and rl.(b)(4).

• Brand Name: RELION PRIME 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: 8730688
• Report Number: 1832816-2019-00012
• Device Sequence Number: 2522087
• Product Code: NBW
• UDI-Device Identifier: 00681131130332
• UDI-Public: (01)00605388022936,(01)00681131130332
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/28/2019

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: 10/29/2020
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 032919A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/25/2019
• 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: 56 YR