MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Catalog Number	07P72-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete list of sample id's are (b)(6).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 alinity c carbon dioxide.When the qc was run on 4 jan, all 3 levels were oor high.Assay calibration corrected the qc issue.Customer then pulled patient samples run prior to the controls and retesting on another analyzer (sn (b)(6) or sn (b)(6) showed a consistent drop in the values of 5-6 mmol/l.The customer provided the following data: lab normal reference ranges are - 2-60 years: 22-29 mmol/l; >60 years: 23-31 mmol/l sample id (b)(6), initial result was 29 and retest result was 23, sample id (b)(6), initial result was 29 and retest result was 22, sample id (b)(6), initial result was 30 and retest result was 23, sample id (b)(6), initial result was 31 and retest result was 24, sample id (b)(6), initial result was 33 and retest result was 25.There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely elevated alinity c carbon dioxide.When the qc was run on 4 jan, all 3 levels were oor high.Assay calibration corrected the qc issue.Customer then pulled patient samples run prior to the controls and retesting on another analyzer (sn (b)(6) or sn (b)(6) showed a consistent drop in the values of 5-6 mmol/l.The customer provided the following data: lab normal reference ranges are - 2-60 years: 22-29 mmol/l; >60 years: 23-31 mmol/l.Sample id (b)(6), initial result was 29 and retest result was 23, sample id (b)(6), initial result was 29 and retest result was 22, sample id (b)(6), initial result was 30 and retest result was 23, sample id (b)(6), initial result was 31 and retest result was 24, sample id (b)(6), initial result was 33 and retest result was 25.There was no reported impact to patient management.
Additional 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, and device history record review.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 ticket search by lot indicates that the reagent lot performs as expected for this product.The ticket trending review did not identify an increase in complaint activity.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c carbon dioxide reagent lot 67123uq10 was identified.

• Brand Name: ALINITY C CARBON DIOXIDE REAGENT KIT
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21519260
• Report Number: 3002809144-2025-00071
• Device Sequence Number: 18227615
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)251130(10)67123UQ10
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 07P72-20
• Device Lot Number: 67123UQ10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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 PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown