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

Model Number 120706

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

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

Event Date 05/23/2017

Event Type  malfunction  

Event Description

Hemocue has received a complaint concerning high values on hemocue glucose 201 analyzer.Observed discrepancy is more than 20%.No patient impact has been reported.

Manufacturer Narrative

The investigation has been performed on the analyzer and remaining microcuvettes received from the customer and also the retained microcuvettes from the same lot.Both the analyzer, customer microcuvettes and retained microcuvettes measured within specification.The problem observed by the customer could not be confirmed.

• Brand Name: HEMOCUE GLUCOSE 201 SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): HEMOCUE AB; p.o.box 1204; ängelholm, 26223 ; SW 26223
• Manufacturer (Section G): HEMOCUE AB; p.o.box 1204; ängelholm, 26223 ; SW 26223
• Manufacturer Contact: maria fagerberg ; p.o.box 1204; ängelholm, 26223 ; SW 26223 ; 31481346
• MDR Report Key: 6656096
• MDR Text Key: 78096058
• Report Number: 3003044483-2017-00008
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2017
• Device Model Number: 120706
• Device Catalogue Number: 110706
• Device Lot Number: 1701205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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