MAUDE Adverse Event Report: ALERE TECHNOLOGIES AS ALERE AFINION HBA1C

Model Number	1115015
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: HBA1C
• Manufacturer (Section D): ALERE TECHNOLOGIES AS; kjelsaasveien 161; oslo, 0884 ; NO 0884
• MDR Report Key: 7791244
• Report Number: 3003045237-2018-00006
• Device Sequence Number: 2508083
• Product Code: LCP
• UDI-Device Identifier: 07070060005683
• UDI-Public: (01)07070060005683(17)200229(11)180213(10)10195435
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other