MAUDE Adverse Event Report: ALERE TECHNOLOGIES AS ALERE AFINION HBA1C

Catalog Number 1115015

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/12/2018

Event Type  malfunction  

Event Description

A customer was tested with alere afinion hba1c and in a lab at the same time.Results from lab test: 6.2%, whole blood collected in a lavender top tube alere afinion hba1c: 8.0% whole blood, fingerstick sample.Test was performed by experienced technician.The date of the event was (b)(6) 2018, and the event was reported on (b)(6) 2018.

• Brand Name: ALERE AFINION HBA1C
• Type of Device: HBA1C
• Manufacturer (Section D): ALERE TECHNOLOGIES AS; kjelsaasveien 161; oslo, 0884 ; NO 0884
• Manufacturer (Section G): ALERE TECHNOLOGIES AS; kjelsaasveien 161; oslo, 0884 ; NO 0884
• Manufacturer Contact: monica vallestad ; kjelsaasveien 161; oslo, 0884 ; NO 0884
• MDR Report Key: 7486434
• MDR Text Key: 107572539
• Report Number: 3003045237-2018-00003
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 07070060011707
• UDI-Public: (01)07070060011707(17)190930(11)170921(10)10190990
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1115015
• Device Lot Number: LN 10190987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1