MAUDE Adverse Event Report: ALERE TECHNOLOGIES AS ALERE AFINION HBA1C

Model Number 1115015

Device Problem High Readings (2459)

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

Event Date 07/12/2018

Event Type  malfunction  

Event Description

A customer reported discrepant results for the alere afinion hba1c on the alere afinion as100 instrument compared to an unknown laboratory method: alere afinion hba1c: 10.6% unknown laboratory method: 5.1 % both samples were collected from the same draw.The sample was sent to an external lab because the result with afinion hba1c was higher than expected.The customer was not able to replicate the result.A sampling of test cartridges from this specific lot were been examined for malfunction with noen observed.No deviations were observed in the handling and storage of samples instrument or test cartridges at the customer site.There is no information available on the laboratory instrument used for comparison.

• 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: 7791244
• MDR Text Key: 117797166
• Report Number: 3003045237-2018-00006
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 07070060005683
• UDI-Public: (01)07070060005683(17)200229(11)180213(10)10195435
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 1115015
• Device Catalogue Number: 1115015
• Device Lot Number: 10195435
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2018
• 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
• Patient Outcome(s): Other