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

Model Number 701102

Device Problems Hole In Material (1293); Low Readings (2460)

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

Event Date 06/04/2014

Event Type  malfunction  

Event Description

Caller indicated the relion prime strips were producing low readings.Customer keeps getting a lo reading - he said that these strips have a hole in them and none of the other bottles he has used had a hole - he just bought the strips yesterday - tests on his finger - no changes in lifestyle - keeps them in the original container -he thinks that something is wrong with just the strips - i explained that we like to do testing with everything he has to try and simulate what he is doing.Replaced product.

Manufacturer Narrative

Device history records were reviewed for the meter and no anomalies were detected.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 ((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: 3900578
• MDR Text Key: 16864228
• Report Number: 1832816-2014-00052
• 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: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Model Number: 701102
• Device Catalogue Number: 701102
• Device Lot Number: 12313A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2014
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2013
• 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