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

Model Number 111716

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

Hemocue received a complaint from a us customer on hemocue glucose 201 microcuvettes.The microcuvettes were reported as being discolored.No patient impact is reported.

Manufacturer Narrative

The results of the investigation of the reserve samples indicate high readings.

• Brand Name: HEMOCUE GLUCOSE 201 MICROCUVETTES
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): HEMOCUE AB; angelholm ; SW
• Manufacturer Contact: charlotte bengtsson, vp qa/ra ; po box 1204; angelholm 26223 ; SW 26223 ; 31481552
• MDR Report Key: 3997992
• MDR Text Key: 17999337
• Report Number: 3003044483-2014-00007
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2014
• Device Model Number: 111716
• Device Lot Number: 131022/8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1