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

Model Number	701102
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2018
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
Caller is reporting high readings.She purchased the meter and test strips three days ago.She stores meter and test strips in bedroom.She does not have any control solution.She is (b)(6) years old.Her birth date is (b)(6).She weighs around (b)(6).Caller is a type 2 diabetic.Caller's normal readings are around 300.Caller should be receiving readings in the 200s according to her doctor.Caller is on steroids, blood pressure medicines, heartburn medicines, cholesterol medicines, painkillers, chemotherapy meds, and is also on insulin.Caller has recently changed her diet.Caller is not on oxygen therapy.Caller cleansed finger with alcohol.Caller tests on fingertip.Caller did not use a new lancet.Caller did not have a problem getting a blood sample.Caller lays the meter down when testing.Meter and test strips have not been exposed to extreme temperatures.Caller received back to back readings of 557 and hi and took 16 units of insulin.Customer was alarmed because readings were so high.Customer called the paramedics.When paramedics arrived, they did a test with their meter and received 357.Customer did another test with her meter and it still read hi.Customer did not have any food or beverages prior to receiving the hi reading.Paramedics did not treat her.Customer did not have any symptoms.Replaced meter, 50ct 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: 7786035
• Report Number: 1832816-2018-00015
• Device Sequence Number: 136275
• Product Code: NBW
• UDI-Device Identifier: 00605388022929
• UDI-Public: (01)00605388022929
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/21/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/19/2018
• Device Model Number: 701102
• Device Catalogue Number: 701102
• Device Lot Number: 052118C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2018
• Initial Report FDA Received Date: 08/15/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 168