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

Model Number 110706

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

Hemocue (b)(4) received a complaint stating that 1 box of hemocue glucose 201 microcuvettes lacked the label.This was detected at a warehouse and the product was not delivered to an end customer, ie there was no patient involved.The box was returned to hemocue (b)(4) for investigation.It could be verified that the label on the box was missing.The box contains 4 separate primary packages of 25 microcuvettes each, all labels on the primary packages (with the same information as on the box label) were in place.During the investigation it was also found that the package insert (instructions for use), that should have been inside the box, was missing.Hemocue (b)(4) has not had any indication that this has occurred previously.An ncr has been opened to investigate the issue and to implement corrections.A capa will be initiated to investigate the root cause of the problem.

• 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 ; po box 1204; angelholm 26223 ; SW 26223 ; 31481552
• MDR Report Key: 4174647
• MDR Text Key: 5098973
• Report Number: 3003044483-2014-00010
• 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: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2015
• Device Model Number: 110706
• Device Lot Number: 1405262
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1