MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATINE KINASE REAGENT KIT; NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

Catalog Number	08P42-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was provided, no additional patient information was available.
Event or Problem Description
The customer observed a falsely decreased alinity c creatine kinase result for one 13-year-old patient.The low result was not reported.The following data was provided (customer¿s reference range is 29-200 u/l): sid (b)(6) processed on(b)(6) 2026 initial result was 576 with dilution.Repeat result = 5993 u/l there was no impact to patient management reported.
Event or Problem Description
The customer observed a falsely decreased alinity c creatine kinase result for one 13-year-old patient.The low result was not reported.The following data was provided (customer¿s reference range is 29-200 u/l): sid (b)(6) processed on (b)(6) 2026 initial result was 576 with dilution.Repeat result = 5993 u/l there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, trending review, labeling review and device history record review.The customer reported event was resolved by replacing the saline pack.Quality controls were within range using the same lot of reagent.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.Ticket trending review for the alinity c creatine kinase reagent did not identify any related trends.Device history record review did not identify any non-conformances or deviations associated with the complaint lot and the complaint issue.Labeling was reviewed and was found to address the customer reported event.Based on the investigation, no systemic issue or deficiency with the alinity c creatine kinase lot 72387un25 was identified.

• Brand Name: ALINITY C CREATINE KINASE REAGENT KIT
• Common Device Name: NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES
• 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: 24443042
• Report Number: 3002809144-2026-00048
• Device Sequence Number: 10212466
• Product Code: CGS
• UDI-Device Identifier: 00380740132590
• UDI-Public: (01)00380740132590(17)260422(10)72387UN25
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K983070
• 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): 05/01/2026

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 Expiration Date: 04/22/2026
• Device Catalogue Number: 08P42-20
• Device Lot Number: 72387UN25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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 Age: 13 YR
• Patient Sex: Female