MAUDE Adverse Event Report: Abbott Laboratories Alinity c Processing Module; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R67-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated magnesium results generated from alinity c processing module for a 74yrs old male patient.The results provided were: on (b)(6) 2026: sid (b)(6): initial=6.71 mg/dl /repeated=1.89 mg/dl.Repeated on alinity (b)(6)=1.94 mg/dl.Customer reference range for magnesium=2.09 to 2.84 mg/dl.There was no reported impact to patient management.
Event or Problem Description
The customer observed falsely elevated magnesium results generated from alinity c processing module for a 74yrs old male patient.The results provided were: on (b)(6)2026: sid (b)(6): initial=6.71 mg/dl /repeated=1.89 mg/dl repeated on alinity (b)(6)=1.94 mg/dl customer reference range for magnesium=2.09 to 2.84 mg/dl there was no reported impact to patient management.
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.E1 postal code is not available, therefore 00000 was entered for form requirement.E1 phone number reached maximum character limit, the complete phone is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
During the requested site visit, the field service engineer (fse) observed that nozzle #5 was clogged and replaced the nozzle c4 #1, #4, #5 (rohs) (7-205228-02).The fsr also replaced additional components, including the worn tubing, peristaltic head (rohs) (7-202464-01) and peristaltic head (rohs) (7-202464-01) which resolved the discrepant result issue.A review of the alinity c processing module, serial number (b)(6) service history found no contributing factors on or around the date of the complaint.A review of tracking and trending of the alinity c processing module or parts did not identify any trends associated with the complaint issue.A review of historical data revealed no trends, systemic issues, or related nonconformances.The alinity ci-series operations manual addresses operational precautions and limitations and troubleshooting of erratic/discrepant results.The alinity c service documentation provides component replacement, removal and verification of the replacement of parts.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Based on the investigation, no product deficiency was identified for either the alinity c processing module, serial number (b)(6), or the nozzle c4 #1, #4, #5 and peristaltic head (rohs).

• Brand Name: Alinity c Processing Module
• Common Device Name: 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 ; +49()6122582960
• MDR Report Key: 50856020
• Report Number: 3016438761-2026-00525
• Device Sequence Number: 9498256
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03R67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C MAG (720T), 08P19-25, 84210UD00; ALNTY C MAG (720T), 08P19-25, 84210UD00
• Patient Age: 74 YR
• Patient Sex: Male