MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION CREATININE2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	04S95-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated creatinine2 on the architect c4000 processing module for one patient.The patient was taking medications novalgina and decadron.The following results were provided (reference range, creatinine 0.60 mg/dl - 1.10 mg/dl): (b)(6) 2024, sid (b)(6), initial creatinine result (analyzer (b)(6) )= 10.67 mg/dl; repeat result (analyzer (b)(6) )= 10.36 mg/dl; from a second blood collection, sid (b)(6), creatinine result (analyzer (b)(6) )= 0.69 mg/dl; from a third blood collection, sid (b)(6), creatinine result (analyzer (b)(6) )= 0.73 mg/dl.The customer reported that the initial creatinine results were from blood drawn from the same limb that iv medication was being administered.There was no impact to patient management reported.
Additional Manufacturer Narrative
Complete entry for section b5 - describe event or problem: (b)(6).Complete entry for section e1 - phone number: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, in-house testing of a retained reagent kit and labeling 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 search for similar complaints for lot 56410ud00 did not identify an increase in complaint activity for the issue.The ticket trending review of complaint data did not identify any related trend regarding commonalities for lot number 56410ud00 and issue.A device history record review did not identify any non-conformances or deviations associated with the lot number 56410ud00 and complaint issue.In house accuracy testing was performed to evaluate assay performance using retained samples of architect creatinine2 reagent lot 56410ud00.Testing met all acceptance criteria and the product is performing as expected.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect creatinine2 reagent for lot number 56410ud00 was identified.
Event or Problem Description
The customer observed falsely elevated creatinine 2 on the architect c4000 processing module for one patient.The patient was taking medications novalgina and decadron.The following results were provided (reference range, creatinine 0.60 mg/dl - 1.10 mg/dl): (b)(6) 2024, sid (b)(6), initial creatinine result (analyzer c460750)= 10.67 mg/dl; repeat result (analyzer c400951)= 10.36 mg/dl; from a second blood collection, sid (b)(6), creatinine result (analyzer c460750)= 0.69 mg/dl; from a third blood collection, sid (b)(6), creatinine result (analyzer c400951)= 0.73 mg/dl.The customer reported that the initial creatinine results were from blood drawn from the same limb that iv medication was being administered.There was no impact to patient management reported.

• Brand Name: CREATININE2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20255977
• Report Number: 3005094123-2024-00482
• Device Sequence Number: 18078133
• Product Code: CGX
• UDI-Device Identifier: 00380740159535
• UDI-Public: (01)00380740159535(17)241212(10)56410UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K210452
• 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): 10/04/2024

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: 12/12/2024
• Device Catalogue Number: 04S95-20
• Device Lot Number: 56410UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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 C4 PROC MOD, 02P24-01, (B)(6) ; ARC C4 PROC MOD, 02P24-01, (B)(6) ; ARC C4 PROC MOD, 02P24-40, (B)(6) ; ARC C4 PROC MOD, 02P24-40, (B)(6)
• Patient Sex: Unknown