MAUDE Adverse Event Report: HEMOCUE AB HEMOCUE HB 201+ SYSTEM

Model Number 111717

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

A hemocue hb 201 system has provided a result that is outside specification when compared to results provided by laboratory methods.This could potentially lead to a missed clinical action if it were to recur.Hemocue: 142 g/l.Lab method 1: 107 g/l.Lab method 2: 106 g/l.No pt impact reported.The user did not take any action based on the result from the hemocue system.

Manufacturer Narrative

The hemocue hb 201+ analyzer was investigated at hemocue using hemocue hb 201 micro-cuvettes returned by the customer from the same lot that was used at the event.No malfunction was detected neither for the analyzer nor the micro-cuvettes.Note that a similar event at the same hosp with the same devices is reported simultaneously, mdr 300304483-2015-00003.

• Brand Name: HEMOCUE HB 201+ SYSTEM
• Manufacturer (Section D): HEMOCUE AB; angelholm ; SW
• Manufacturer Contact: maria fagerberg, ra mgr ; po box 1204; angelholm 26223 ; SW 26223 ; 31481346
• MDR Report Key: 4563448
• MDR Text Key: 5547225
• Report Number: 3003044483-2015-00002
• Device Sequence Number: 1
• Product Code: GKR
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K032203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 111717
• Device Catalogue Number: 121701
• Device Lot Number: 1406862
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• 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