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	Low Test Results (2458)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history records were reviewed, and no anomalies were detected. retain strips of specified lot were tested with reference meter and passed testing with no failures detected.Actual product was not returned.If either meter or strips is returned, arkray will evaluate the product and file a follow-up report.
Event or Problem Description
Caller has two prime meters.(b)(4) which is six months old, and (b)(4), which was purchased on (b)(6) 2019 and 25 ct.Strip lot 012119a with expiration 2020-08-15.Customer first tested on (b)(6) 2019 and was receiving low readings (54 and 40).Customer normally tests between 130-160.New meter (b)(4) was purchased on (b)(6) 2019 and caller was receiving low readings with this meter as well (52 and 57).Customer stated she was eating food and drinks that she normally wouldn't eat or drink to get sugar up.Customer started feeling tired and went to er on (b)(6) 2019 at about 3 am.She completed a blood test with her new prime meter while there and received 58.Er did a reading with their meter and received 168.Blood work showed a reading of 199 for glucose.No medications given.Customer now will have an er bill.Replaced meters, strips and sent rl.

• 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: 9429461
• Report Number: 1832816-2019-00030
• Device Sequence Number: 2237975
• Product Code: NBW
• UDI-Device Identifier: 00681131130332
• UDI-Public: (01)00605388022936,(01)00681131130332
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/12/2019

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: 08/15/2020
• Device Model Number: 701103
• Device Catalogue Number: 701103
• Device Lot Number: 012119A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/06/2019
• 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: 43 YR
• Patient Weight: 102