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 07/09/2023

Event Type  malfunction  

Event Description

The customer reported that they were having trouble with the sample pipettor on the alinity c processing module and communicated the following error codes occurred, 5689 - sample pipettor movement restricted and 9415 - processing module c error.It was reported that sparks were observed when the chassis of the sample positioner encoder touched the frame of the instrument.A pinched cable on the a1c wash valve was discovered.The a1c cable was found to be shorted out.A short was also discovered in cnn 9 and the sio board was replaced.No further sparks were observed.There was no reported impact to patient management.

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.

Event Description

The customer reported that they were having trouble with the sample pipettor on the alinity c processing module and communicated the following error codes occurred, (b)(6) - sample pipettor movement restricted and (b)(6) - processing module c error.It was reported that sparks were observed when the chassis of the sample positioner encoder touched the frame of the instrument.A pinched cable on the a1c wash valve was discovered.The a1c cable was found to be shorted out.A short was also discovered in cnn 9 and the sio board was replaced.No further sparks were observed.There was no reported impact to patient management.

Manufacturer Narrative

The alinity c processing module, serial number (b)(6) was inspected.It was discovered that the power issue was coming from sio board and that the carrier positioner motor encoder/home cable had shorted to the frame.No fire or smoke was seen nor any damage other parts of the instrument.The sio board and the carrier positioner motor encoder/home cable were replaced.Return testing was not completed as returns were not available.The instrument service history review revealed no additional issues related to the reported event.A review of tracking and trending did not identify a trend for the sio board or the carrier positioner motor encoder/home cable and review found no similar issues with regards to the reported issue.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances related to the sio board or the carrier positioner motor encoder/home cable.A labeling review determined product labeling addresses troubleshooting and provides resolution for the reported event.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 short-circuited part observed, due to the power issue coming from sio driver bd was limited to the carrier positioner motor encoder/home cable; the short-circuit issue did not spread to other parts of the module.No fire or smoke was seen nor any damage other parts of the instrument.Based on the available information, no systemic issue or deficiency was identified for the alinity c processing module, serial number (b)(6), sio board, or the carrier positioner motor encoder/home cable.

• 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: 17452027
• MDR Text Key: 320320105
• Report Number: 3016438761-2023-00414
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: 00380740137380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• 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: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1