MAUDE Adverse Event Report: ALERE TECHNOLOGIES AS ALERE AFINION HBA1C

Model Number	1115015
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Discrepant (b)(6) results compared to lab: 5 patient samples/ 1 analyzer.Customer reported 5 discrepant patient results: (b)(6).Lab samples were venous draw purple top tubes- no test dates or further information regarding the lab results were provided.

• Brand Name: ALERE AFINION HBA1C
• Common Device Name: HBA1C
• Manufacturer (Section D): ALERE TECHNOLOGIES AS; kjelsaasveien 161; oslo 0884 ; NO 0884
• MDR Report Key: 7486437
• Report Number: 3003045237-2018-00004
• Device Sequence Number: 1339159
• Product Code: LCP
• UDI-Device Identifier: 07070060005683
• UDI-Public: (01)07070060005683(17)19093+(11)171009(10)10193211
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 1115015
• Device Catalogue Number: 1115015
• Device Lot Number: 10193211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1