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

Catalog Number 03R67-01

Device Problem Sparking (2595)

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

Event Date 07/25/2023

Event Type  malfunction  

Event Description

The technical service specialist (tss) was onsite performing maintenance on the alinity c processing module, when he observed an arc and sparks seen between the housing of the sample positioner encoder and the screwdriver of the tss.The metallic weld seams clearly recognizable due to high current contact.The screwdriver was on a chassis screw of the rsm idler pulley on the left.The voltage measurement between the housing sample position encoder and the screw revealed -24v dc.The tss checked several screw points, and all are at +24v dc potential.The tss replaced the sample encoder, however the error persisted.After other troubleshooting tasks performed it was found that a system error was triggered by a defective latch solenoid mixer 2.The mixer 2 assembly was replaced, and the error had been corrected.No short circuit or voltage on the system housing was found.No harm or injuries were reported.There was no impact to patient management or user safety reported.

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Service discovered a system error was triggered by a defective latch solenoid mixer 2 on the alinity c processing module, serial number (b)(6) while performing maintenance on the instrument.The mixer 2 assy, complete (part number c-35016529-03) was replaced and deemed the likely cause for the observed spark.No injury to personnel was reported.No fire or smoke was seen nor any damage other parts of the instrument.Pictures depicting the observed issue were attached to the ticket.A review of the instrument service history revealed no additional issues of sparks from a part reported on the alinity c processing module, serial number (b)(6).A review of tracking and trending did not identify any related trends.A review of the device history record did not identify any non-conformances or deviations for the mixer 2 assy, complete or the alinity c processing module with regards to the complaint issue.Labeling was reviewed and adequately addresses the issue under review.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 spark observed, due to the triggered system error by a defective latch solenoid mixer 2 was limited to the mixer 2 assy, complete (part number c-35016529-03); the sparks did not spread to other parts of the module.Based on the investigation, no systemic issue or product deficiency was identified for the mixer 2 assy, complete or the alinity c processing module, serial number (b)(6).Section g1 contact information was updated to reflect the current contact (b)(6).

Event Description

The technical service specialist (tss) was on site performing maintenance on the alinity c processing module, when he observed an arc and sparks seen between the housing of the sample positioner encoder and the screwdriver of the tss.The metallic weld seams clearly recognizable due to high current contact.The screwdriver was on a chassis screw of the rsm idler pulley on the left.The voltage measurement between the housing sample position encoder and the screw revealed -24v dc.The tss checked several screw points, and all are at +24v dc potential.The tss replaced the sample encoder, however the error persisted.After other troubleshooting tasks performed it was found that a system error was triggered by a defective latch solenoid mixer 2.The mixer 2 assembly was replaced, and the error had been corrected.No short circuit or voltage on the system housing was found.No harm or injuries were reported.There was no impact to patient management or user safety reported.

• Brand Name: ALINITY C 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: 17447485
• MDR Text Key: 320301306
• Report Number: 3016438761-2023-00413
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: 00380740137380
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1