MAUDE Adverse Event Report: ARKRAY, INC. GLUCOCARD VITAL BLOOD GLUCOSE SYSTEM; BLOOD GLUCOSE TEST SYSTEM

Model Number 760050

Device Problems Improper or Incorrect Procedure or Method (2017); Low Readings (2460)

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

Event Date 12/04/2014

Event Type  malfunction  

Event Description

Caller indicated the relion prime strips were producing low results.Got a reading of lo this morning and another reading of lo when she tested at lunch time several hours later.She did not feel like her blood glucose was low at all.Technique is ok.Does store strips in the bathroom advised her not to.She also did a control solution test and the result was 32.Says this is the first time she's used the control solution.Advised her to send back meter strips and solution.Replacing 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: GLUCOCARD VITAL 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: 4332871
• MDR Text Key: 16859232
• Report Number: 1832816-2014-00091
• 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: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2016
• Device Model Number: 760050
• Device Catalogue Number: 760050
• Device Lot Number: 06264B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2014
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2014
• 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