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

Catalog Number 110706

Device Problem Material Discolored (1170)

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

Event Date 07/27/2017

Event Type  malfunction  

Event Description

Hemocue has received a complaint concerning discolored hemocue glucose 201 microcuvettes and mold or dirt in the vials.

Manufacturer Narrative

The investigation has been performed on the remaining microcuvettes received from the customer and also the retained microcuvettes from the same lot.The reported mold/dirt is small residuals from the microcuvettes that can fall off during transportation of the microcuvettes.The degree of discoloration after customer opened microcuvettes could not be evaluated since the first picture was taken after 1 week of storage at wrong temperature which impact the discoloration.Both retained and customer microcuvettes measure within specification.

• Brand Name: HEMOCUE GLUCOSE 201 MICROCUVETTES
• 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
• MDR Report Key: 6822131
• MDR Text Key: 83747622
• Report Number: 3003044483-2017-00009
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2017
• Device Catalogue Number: 110706
• Device Lot Number: 1611236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1