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

Model Number	500001
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter involved in incident was returned for evaluation.Meter was evaluated with retain strips of specified lot and performed to specification.No failure detected.
Event or Problem Description
Facility has had the meter for 6-9 months.The serial number is wiped off.Assigned temporary serial number (b)(4).The nurse performed back to back blood tests and received 24, then received 94 less than a minute a part.They did not perform a control solution test as the caller did not have control solution.Patient was stable and did not need medical attention.The readings provided fell in zone c on parkes consensus grid.Replaced meter, test strips and sent return label.

• Brand Name: ASSURE PLATINUM 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: 9249909
• Report Number: 1832816-2019-00026
• Device Sequence Number: 2105001
• Product Code: NBW
• UDI-Device Identifier: 00015482500504
• UDI-Public: (01)00015482500016,(01)00015482500504
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K092104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: 500001
• Device Catalogue Number: 500001
• Device Lot Number: 082019A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR