MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C16000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 03L77-01

Device Problem Low Test Results (2458)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely decreased sodium results generated on the architect c16000 processing module for four patients.The samples were repeated and higher results were obtained.The following data was provided: patient 1: (b)(6) 2024 sodium initial result = 113.1 mmol/l; repeat result = 138.4 mmol/l.Patient 2: (b)(6) 2024 sodium initial result = 113.0 mmol/l; repeat result = 139.3 mmol/l.Patient 3: sodium initial result = 113.0 mmol/l; repeat result = 139.3 mmol/l.Patient 4: (b)(6) 2024 sodium initial result = 120.0 mmol/l; repeat result = 140.0 mmol/l.Approximate reference (normal) range: 136 to 145 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

Section a1 - patient identifier: patient 1, patient 2, patient 3, patient 4, patient 5, patient 6.Section b5-describe event or problem: this section was updated to include additional information provided by the customer on (b)(6)2024.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

Update: on (b)(6)2024, the customer observed falsely decreased sodium results for two additional patients.The samples were repeated and normal results were obtained.The following data was provided: patient 5: (b)(6)2024 sodium initial result = 107 mmol/l; repeat result = 137 mmol/l patient 6: (b)(6)2024 sodium initial result = 112.8 mmol/l; repeat result = 137.7 mmol/l there was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.The ict sample diluent is used for analysis of electrolytes on the architect c16000 processing module.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends regarding commonalities for complaint lot.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the ict sample diluent in the field was reviewed using data gathered from customers worldwide.The patient median values obtained with the complaint lot 92390un23 is within established limits and thus comparable to the historical lot performance, which confirms no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect c16000 processing module for serial (b)(6) or the ict sample diluent, lot number 92390un23 were identified.

Event Description

The customer observed falsely decreased sodium results generated on the architect c16000 processing module for four patients.The samples were repeated and higher results were obtained.The following data was provided: patient 1: (b)(6) 2024 sodium initial result = 113.1 mmol/l; repeat result = 138.4 mmol/l.Patient 2: (b)(6) 2024 sodium initial result = 113.0 mmol/l; repeat result = 139.3 mmol/l.Patient 3: sodium initial result = 113.0 mmol/l; repeat result = 139.3 mmol/l.Patient 4: (b)(6) 2024 sodium initial result = 120.0 mmol/l; repeat result = 140.0 mmol/l.Approximate reference (normal) range: 136 to 145 mmol/l.There was no impact to patient management reported.Update: on (b)(6) 2024, the customer observed falsely decreased sodium results for two additional patients.The samples were repeated and normal results were obtained.The following data was provided: patient 5: (b)(6) 2024 sodium initial result = 107 mmol/l; repeat result = 137 mmol/l.Patient 6: (b)(6) 2024 sodium initial result = 112.8 mmol/l; repeat result = 137.7 mmol/l.There was no impact to patient management reported.

• Brand Name: ARCHITECT C16000
• 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: 19051486
• MDR Text Key: 340112943
• Report Number: 3016438761-2024-00196
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONC ICT DILUENT, 02P32-11, (B)(6) ; CONC ICT DILUENT, 02P32-11, (B)(6) ; CONC ICT DILUENT, 02P32-11, (B)(6)