MAUDE Adverse Event Report: ALERE TECHNOLOGIES AS ALERE AFINION ACR CONTROL

Model Number 1115239

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer complaints regarding alere afinion acr control with out of range albumin values have been reported.The customer complaints are related to two afinion acr control c i lots and two afinion control c ii lots which are components of three different kit lots of afinion acr control.Internal investigation has revealed an error in the albumin target setting of the control lots involved in the complaints.Control c i and control c ii lot numbers, expiry dates, target values and acceptable ranges for albumin and creatinine are stated on a label on the front page of the alere afinion acr control package insert.The incorrect target values and acceptable ranges stated in the package insert for the affected afinion acr control lots is regarded as mislabelling.The affected lots are manufactured in november 2017 and january 2018 and distributed to customers in (b)(4) in the period (b)(4) 2017 - (b)(4) 2018.The remaining kits from the affected lots in the manufacturer's warehouse and with the distributors have been put on quality hold and will be discarded.The incident is regarded as mislabeling and field corrective actions have been initiated.A fsn will be distributed to all customers who have received kits from the affected lots.The mislabeled kits at the customers' sites will be replaced with alere afinion acr control kits from a new lot with correctly assigned target values.

• Brand Name: ALERE AFINION ACR CONTROL
• Type of Device: ACR CONTROL
• Manufacturer (Section D): ALERE TECHNOLOGIES AS; kjelsaasveien 161; oslo, oslo 0884 ; NO 0884
• Manufacturer (Section G): ALERE TECHNOLOGIES AS; kjelsaasveien 161; oslo, oslo 1884 ; NO 1884
• Manufacturer Contact: monica vallestad ; kjelsaasveien 161; oslo, oslo 1884 ; NO 1884
• MDR Report Key: 7486430
• MDR Text Key: 107732355
• Report Number: 3003045237-2018-00002
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 1115239
• Device Catalogue Number: 1115239
• Device Lot Number: 10193871, 10195065
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1