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

Catalog Number	07D63-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed creatine kinase results for one patient.The following results from one patient were provided: sid (b)(6).Initial run (error code 1350 ¿unable to calculate result no absorbance reads within absorbance range¿).Dilution: 1:2, no result ec1350.Results were generated with diluted sample (1:10): <70 u/l.Repeat run on sn (b)(6).(error code 1350 ¿unable to calculate result no absorbance reads within absorbance range¿), dilution:1:2, no result, ec 1350.Dilution:1:10, result >42670 u/l.Sid (b)(6).Initial run (error code 1350 ¿unable to calculate result no absorbance reads within absorbance range¿) diluted specimen 1:2, no result ec 1350.Diluted specimen 1:10; result:<70 u/l.Repeat run on sn (b)(6).(error code 1350 ¿unable to calculate result no absorbance reads within absorbance range¿), dilution:1:2, no result ec 1350, dilution:1:10, result >42670.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.
Additional Manufacturer Narrative
Corrected data: a1 - patient identifier updated to reflect one patient.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 complaint lot performs as expected for this product.Ticket trending review did not identify any trends.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 architect creatine kinase reagent lot 72896un23 was identified.
Event or Problem Description
The customer observed falsely depressed creatine kinase results for one patient.The following results from one patient were provided: sid (b)(6) initial run (error code 1350 ¿unable to calculate result no absorbance reads within absorbance range¿) dilution: 1:2, no result ec1350 results were generated with diluted sample (1:10): <70 u/l repeat run on sn (b)(6) (error code 1350 ¿unable to calculate result no absorbance reads within absorbance range¿), dilution:1:2, no result, ec 1350 dilution:1:10, result >42670 u/l sid (b)(6) initial run (error code 1350 ¿unable to calculate result no absorbance reads within absorbance range¿) diluted specimen 1:2, no result ec 1350 diluted specimen 1:10; result:<70 u/l repeat run on sn (b)(6) (error code 1350 ¿unable to calculate result no absorbance reads within absorbance range¿), dilution:1:2, no result ec 1350 dilution:1:10, result >42670.No impact to patient management was reported.

• Brand Name: CREATINE KINASE
• 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: 19156592
• Report Number: 3002809144-2024-00124
• Device Sequence Number: 12623433
• Product Code: CGS
• UDI-Device Identifier: 00380740161699
• UDI-Public: (01)00380740161699(17)240411(10)72896UN23
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 06/21/2024

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 Expiration Date: 04/11/2024
• Device Catalogue Number: 07D63-22
• Device Lot Number: 72896UN23
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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: ARC C4000 INTGR, 02P24-40, C401263; ARC C4000 INTGR, 02P24-40, C401263
• Patient Sex: Unknown