ALERE AFINION AS100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-18 for ALERE AFINION AS100 manufactured by Abbott Diagnostics Technologies As.

Event Text Entries

[188868402] The customer experience static shock from the afinion analyzer and the analyzer would not turn on after this incident. There were no sparks, burning or smoking. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003045237-2020-00003
• MDR Report Key: 9849996
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-03-18
• Date of Report: 2020-03-18
• Date of Event: 2020-02-28
• Date Mfgr Received: 2020-02-28
• Date Added to Maude: 2020-03-18
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS MONICA VALLESTAD
• Manufacturer Street: KJELS P.O.BOX 6863 RODEL
• Manufacturer City: OSLO, 0504
• Manufacturer Country: NO
• Manufacturer Postal: 0504
• Manufacturer G1: ABBOTT DIAGNOSTICS TECHNOLOGIES AS
• Manufacturer Street: KJELS P.O.BOX 6863 RODEL
• Manufacturer City: OSLO, 0504
• Manufacturer Country: NO
• Manufacturer Postal Code: 0504
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ALERE AFINION AS100
• Generic Name: ANALYZER
• Product Code: JQT
• Date Received: 2020-03-18
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABBOTT DIAGNOSTICS TECHNOLOGIES AS
• Manufacturer Address: KJELS?SVEIEN 161 P.O.BOX 6863 RODEL?KKA OSLO, 0504 NO 0504

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-18