MAUDE Adverse Event Report: ARKRAY FACTORY USA, INC. RELION PRIME TEST STRIPS; GLUCOSE OXIDASE, GLUCOSE

Model Number	700100
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer returned two bottles of specified strips.Bottle 1 was returned with 46 strips; six of these strips were tested, and failed testing reading lo on all three blood levels confirming the complaint.Bottle 2 was returned with 50 strips and passed testing with no failures detected.Two bottles of retain strips were tested as well.Bottle 1 of retains failed testing reading lo on the 150mg/dl and 300mg/dl blood levels.Bottle 2 of retains passed testing with no failures detected.Desiccant testing was performed on failed strip bottles and passed testing indicating moisture intrusion is not the cause of the observed strip failure, indicating that user error is most likely not a factor in the confirmed failure.Complaint products will be forwarded to the manufacturer for further investigation.
Event or Problem Description
Customer reported issues of low blood readings.Complaint was reviewed for investigation and reportability on (b)(6) 2022.Complaint was marked for investigation and determined not reportable per arkray's per internal procedures.On (b)(6) 2022, returned strips failed testing by generating low results out of specification.The strips gave low readings, making this complaint reportable to the manufacturer as a malfunction.(b)(6) 2022 marks the aware date for mdr filing.

• Brand Name: RELION PRIME TEST STRIPS
• Common Device Name: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): ARKRAY FACTORY USA, INC.; 5182 w 76th street; minneapolis MN 55439
• Manufacturer (Section G): ARKRAY FACTORY USA, INC.; 5182 w 76th street; minneapolis MN 55439
• Manufacturer Contact: tom speikers ; 5182 w 76th street; minneapolis, MN 55439 ; 9526463168
• MDR Report Key: 14208900
• Report Number: 1832816-2022-00004
• Device Sequence Number: 14843485
• Product Code: CGA
• UDI-Device Identifier: 00605388022943
• UDI-Public: (01)00605388022943
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K091102/001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/13/2023
• Device Model Number: 700100
• Device Catalogue Number: 700100
• Device Lot Number: 122921B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male