MAUDE Adverse Event Report: ABBOTT DIAGNOSITCS TECHNOLOGIES AS ALERE AFINION AS100 ANALYZER

Model Number 1116054

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Event Description

A complaint was received describing that a short circuit occurred when the customer was using the alere afinion as100.There was a sound and burnt smell, there was no electric shock.No person was hurt and no equipment was damaged.

Manufacturer Narrative

Additions from previous report: d4: added serial number.G7: added type of report: follow up # 1.H7: selection recall included.H9 included reference to recall.H10: added narrative data.

• Brand Name: ALERE AFINION AS100 ANALYZER
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSITCS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo, 0504 ; NO 0504
• MDR Report Key: 9510460
• MDR Text Key: 188869073
• Report Number: 3003045237-2019-00005
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• PMA/PMN Number: K151809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 1116054
• Device Catalogue Number: 1116054
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9613069-02/03/2020-001-C
• Patient Sequence Number: 1