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

Model Number 700050

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2014

Event Type  malfunction  

Event Description

Caller indicated the relion prime strips were producing low results.Constantly getting "lo" on meter.Got control solution and tested strips and were still low.Got new strips and all is working well.Replaced product.

Manufacturer Narrative

Product involved in incident was returned and evaluated.The returned product gave 'lo' results confirming the complaint.Retention samples of the same lot of test strips involved in the incident were tested and performed to specification.Manufacturer is aware of the issue which is under investigation (capa (b)(4)).

• Brand Name: RELION PRIME BLOOD GLUCOSE SYSTEM
• Type of Device: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): ARKRAY, INC.; 57 nishiaketa-cho,; higashi-kujo, minami-ku,; kyoto, 601- 8045; JA 601-8045
• Manufacturer (Section G): ARKRAY, INC.; 57 nishiaketa-cho,; higashi-kujo, minami-ku,; kyoto, 601- 8045; JA 601-8045
• Manufacturer Contact: tom speikers ; 5182 west 76th street; minneapolis, MN 55439 ; 9526463168
• MDR Report Key: 3919881
• MDR Text Key: 18067886
• Report Number: 1832816-2014-00056
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/08/2014

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: 700050
• Device Catalogue Number: 700050
• Device Lot Number: 04014D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2014
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1