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	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated magnesium generated from a alinity c processing module and provided the following data: customer reference range for magnesium is 1.6 to 2.6 mg/dl.On 5 apr 2024, sample id (b)(6) generated magnesium result of 7.84 mg/dl, which was reportedly flagged as a critical result.The sample was repeated and generated results of 1.72, 1.69, 1.75.Troubleshooting was performed, which involved analyzer adjustments and replacing an analyzer part.Precision was ran with 10 high and 10 low samples, which all generated results in the acceptable range.Additional laboratory values provided: sodium was 137.8 & 138.4 mmol/l, phosphorus was 3.5 & 3.5 mg/dl, total protein was 7.14 & 7.15 g/dl, urea was 15.6 & 15.7 mg/dl.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated magnesium generated from a alinity c processing module and provided the following data: customer reference range for magnesium is 1.6 to 2.6 mg/dl.On (b)(6) 2024, sample id (b)(6) generated magnesium result of 7.84 mg/dl, which was reportedly flagged as a critical result.The sample was repeated and generated results of 1.72, 1.69, 1.75.Troubleshooting was performed, which involved analyzer adjustments and replacing an analyzer part.Precision was ran with 10 high and 10 low samples, which all generated results in the acceptable range.Additional laboratory values provided: sodium was 137.8 & 138.4 mmol/l, phosphorus was 3.5 & 3.5 mg/dl, total protein was 7.14 & 7.15 g/dl, urea was 15.6 & 15.7 mg/dl.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.
Additional Manufacturer Narrative
The alinity c processing module, serial #(b)(6) was evaluated, and it was observed that there was a substance on the mixer and there was low wash flow to the cuvette washer.The issue was resolved by replacing the mixer and adjusting the cuvette washer flow rate.No additional discrepant result issues have been reported since the service activity was completed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no subsequent issues have been reported associated with the customer reported event.A review of tracking and trending did not identify a trend for the mixer or the alinity c system with regards to the customer reported event.A review of the manufacturing documentation did not identify any related non-conformances or potential non-conformances for the mixer as it relates to the customer reported event.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified.

• 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 ; 6122582960
• MDR Report Key: 19167551
• Report Number: 3016438761-2024-00228
• Device Sequence Number: 7949068
• Product Code: JJE
• UDI-Device Identifier: 00380740176532
• UDI-Public: (01)00380740176532
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03R67-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C MAG (3600T), 08P19-34, 57143UD00; ALNTY C MAG (3600T), 08P19-34, 57143UD00
• Patient Sex: Unknown