MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS TECHNOLOGIES AS AFINION 2; ANALYZER

Model Number 1116778

Device Problems Failure to Power Up (1476); Sparking (2595); Power Problem (3010)

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

Event Date 12/27/2022

Event Type  malfunction  

Event Description

28 dec 2022: technical service (ts) received email from customer who reported that they obtained information code 120 on their afinion analyzer s/n (b)(4), (sw not provided) and turned black.(b)(6) 2022: customer informed ts by email there had been sparks from the instrument.Not patient or user was harmed.

Manufacturer Narrative

Device requested, but not yet returned.

Manufacturer Narrative

The risks are evaluated to be in the low risk region for the user/patient.The risks show that the event is corresponding with what is anticipated for the nature and severity of the product.The event does not represent any new or unanticipated failure mode or hazard/harm combination.The case details were reviewed along with internal records and no nonconformances were identified.There were no adverse patient effects and no clinically significant delay in the procedure reported in the complaint case.Our investigation determined that there is no indication that the reported issue is related to product results, inadequate instructions for use or inaccurate labeling.

Event Description

28 dec 2022: technical service (ts) received email from customer who reported that they obtained information code 120 on their afinion analyzer s/n (b)(6), (sw not provided) and turned black.(b)(6) 2022: customer informed ts by email there had been sparks from the instrument not patient or user was harmed.

• Brand Name: AFINION 2
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; po box 6863 rodelokka; oslo NO050 4; NO NO0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; po box 6863 rodelokka; oslo NO050 4; NO NO0504
• Manufacturer Contact: claire dora ; kjelsåsveien 161; po box 6863 rodelokka; oslo NO050-4 ; NO NO0504
• MDR Report Key: 16202953
• MDR Text Key: 308209091
• Report Number: 9613069-2023-00001
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K171650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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 Operator: Health Professional
• Device Model Number: 1116778
• Device Catalogue Number: 1116778
• Device Lot Number: 10218276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• 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