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

Catalog Number 120706

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

A hemocue glucose 201 system gives off results compared to lab.The hemocue system shows 84mg/dl and lab 384mg/dl.No pt impact reported.

• Brand Name: HEMOCUE GLUCOSE 201 SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): HEMOCUE AB; angelholm ; SW
• Manufacturer Contact: maria fagerberg, ra manager ; po box 1204; angelholm SE-26-223 ; SW SE-26223 ; 31481346
• MDR Report Key: 4644666
• MDR Text Key: 5680652
• Report Number: 3003044483-2015-00015
• Device Sequence Number: 1
• Product Code: CGA
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 120706
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1