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

Model Number AS100

Device Problems Sparking (2595); Fail-Safe Problem (2936); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

Customer did not attempt to power up or use the analyzer after sparking, instrument was unplugged.

Event Description

On (b)(6) 2023: customer called in to report receiving a 302 code (analyzer failure) with tests.Customer also hears a grinding noise during test.Technical support asked customer to disconnect and reconnect the power.When customer unplugged the power cord from the surge protector she noticed a spark.Spark came from the cord.The customer was not injured.There was no visible damage from the power cord or analyzer.Customer was unsure if original power supply was used.The instrument is located in a dry environment, clinic setting, at room temperature.User has not experienced other instances of static electricity in general and was wearing business casual clothing.

• Brand Name: ALERE AFINION AS100 ANALYZER
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer Contact: claire dora ; po box 6863 rodelokka; oslo NO-05-04 ; NO NO-0504 ; 24056000
• MDR Report Key: 17910553
• MDR Text Key: 325821840
• Report Number: 9613069-2023-00004
• Device Sequence Number: 1
• Product Code: JQT
• 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: User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/11/2023

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 Model Number: AS100
• Device Catalogue Number: 1115390
• Device Lot Number: 10175334
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1