MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY I PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 03R65-01

Device Problem Sparking (2595)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

The customer observed vacuum errors on the alinity i processing module, serial number (b)(6).The customer observed the vacuum pump was sparking.The instrument went to stopped mode.No fire, smoke or injury was reported.Null.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed vacuum errors on the alinity i processing module, serial number (b)(6).The customer observed the vacuum pump was sparking.The instrument went to stopped mode.No fire, smoke or injury was reported.

Manufacturer Narrative

Service was dispatched for the alinity i, serial # (b)(6) generating message error codes on the vacuum pump and sparks coming from the control board, vacuum pump universal on the module.No fire or smoke was seen nor any damage to the instrument.The power to the module was turned off and there was no injury to personnel reported.Service replaced the control board, vacuum pump universal (part number a-35017343-01) as the likely cause for issue as the board showed evidence of charring/burn on board.Replacement of the control board, vacuum pump universal was considered the issue resolution.A review of the service history for the alinity i processing module, serial number (b)(6) revealed no contributing factor on or around the date of the event or any further issue of sparks.A review of tracking and trending did not identify any trends for the alinity i processing module or the control board, vacuum pump universal (part number a-35017343-01).The 2023 ul certification memo indicates that abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.The alinity i system operations manual provides information regarding electrical hazards, and electrical safety for the alinity i systems.Based on the available information, no systemic issue or deficiency of the control board, vacuum pump universal (part number a-35017343-01) or the alinity i processing module, serial number (b)(6) was identified.The following sections have been corrected to reflect the current contact (b)(6): g1-contact office first name, g1-contact office last name, g1-contact office address 1, g1-contact office city, g1-contact office postal code, g1-contact office country, g1-contact office phone number, g1-contact office email, g1-contact office fax number.

• Brand Name: ALINITY I PROCESSING MODULE
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17825056
• MDR Text Key: 324359842
• Report Number: 3016438761-2023-00518
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: 00380740137366
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R65-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONTROL BOARD, VACUUM PUMP UNIVERSAL, A-35017343-0.