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

Model Number	701102
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records were reviewed, and no anomalies were detected. arkray was unable to contact the customer to gather more information or request the return of subject meter.Actual product was not returned for testing and lot number is not known so retention samples could not be tested. if either strips or meter is returned, arkray will evaluate the product and file a follow-up report.
Event or Problem Description
Caller's name is (b)(6).Caller wanted to know how to test a meter.I inquired what the caller meant, and then explained control solution testing.The caller reported this morning his brother was testing his sugar and his sugar was 30 points off compared to the paramedic's meter.Caller stated the meter was old.Caller stated patient has had his meter for five years.I offered replacement meter and explained shipping information.I called caller back to gather information for the incident report.Incident happened this morning ((b)(6) 2020).When asked about the test strip information, the caller stated he was in the car right now going to the store, so he did not have the test strip lot and expiration information with him.Caller stated the test strips have been opened less than 90 days.The meter and strips are stored together in the living room cabinet.The meter and strips have not been exposed to extreme temperatures.The caller then stated he had to get going and when asked if he could call back later, he stated "no, i'm very busy and have things to do".When asked why he thinks the meter is not working properly, the caller stated, "it was off compared to the paramedic's meter and their meter is tested every week".The caller stated it was a 30-point difference.Unsure if the reading was higher or lower.Caller then stated that he was the one that assessed "that the meter was lying to them".Caller then stated again that he had to get going and needed to end the call and abruptly ended the call.We attempted to contact the caller three more times to get more information but were unable to reach the caller.Replaced meter and 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, 520-3 306; JA 520-3306
• MDR Report Key: 10521714
• Report Number: 1832816-2020-00020
• Device Sequence Number: 3155566
• Product Code: NBW
• UDI-Device Identifier: 00605388022929
• UDI-Public: (01)00605388022929
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 701102
• Device Catalogue Number: 701102
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/11/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 70