MAUDE Adverse Event Report: HEMOCUE AB HEMOCUE GLUCOSE 201 MICROCUVETTES; GLUCOSE TEST SYSTEM

Model Number 11716

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2014

Event Type  malfunction  

Event Description

During an internal investigation on retention samples, hemocue glucose 201 microcuvettes showed results outside specification.No patient is involved and no info from the field concerning this batch has been rec'd that indicates similar problems.

• Brand Name: HEMOCUE GLUCOSE 201 MICROCUVETTES
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): HEMOCUE AB; angelholm ; SW
• Manufacturer Contact: charlotte bengtsson, vp ra/qa ; p.o. box 1204; angelholm SE-26-2 23 ; SW SE-262 23 ; 31481552
• MDR Report Key: 3998237
• MDR Text Key: 4709705
• Report Number: 3003044483-2014-00005
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K020935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/12/2014
• Device Model Number: 11716
• Device Lot Number: 1310252
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• 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