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

Catalog Number 03R67-01

Device Problem Low Test Results (2458)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

The customer observed a falsely depressed sodium result generated on the alinity c processing module for one sample.The following data was provided (customer provided normal range: 135 to 145 mmol/l): 11mar2024 sid (b)(6) initial result = 105 mmol/l, repeat = 138 mmol/l patient historical result = 140 mmol/l no impact to patient management was reported.

Manufacturer Narrative

Completed information for section a1 patient identifier: sid (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

The field service representative (fsr) inspected the alinity c processing module, performed multiple troubleshooting procedures, including part replacement.However, no definitive part was identified as the issue.Return testing was not completed as returns were not available.An instrument service history review revealed no additional service tickets associated with discrepant /erratic results on the (b)(6).There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending of the alinity system did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the alinity c processing module for serial (b)(6) was identified.

Event Description

The customer observed a falsely depressed sodium result generated on the alinity c processing module for one sample.The following data was provided (customer provided normal range: 135 to 145 mmol/l): (b)(6) 2024 sid (b)(6) initial result = 105 mmol/l, repeat = 138 mmol/l.Patient historical result = 140 mmol/l.No impact to patient management was 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: 19003741
• MDR Text Key: 338982552
• Report Number: 3016438761-2024-00181
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: (01)00380740137380
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/24/2024

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 Catalogue Number: 03R67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1