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 01/08/2015

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: 126 g/l.Lab method 1: 77 g/l.Lab method 2: 78 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 microcuvettes returned by the customer from the same lot that was used at the event.No malfunction was detected neither for the analyzer nor the microcuvettes.Note that a similar event at the same hosp with the same devices is reported simultaneously, mdr 300304483-2015-00002.

• 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: 4563459
• MDR Text Key: 5546708
• Report Number: 3003044483-2015-00003
• 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