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

Catalog Number 04S95-20

Device Problem High Test Results (2457)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

The customer observed a falsely elevated creatinine2 result generated on the architect c4000 processing module for one sample.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 8.53 mg/dl the patient was retested at another hospital = 0.92 mg/dl the quality controls shifted up but was within range for level 1 and 3.Level 2 was out of range high.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

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 in-house testing of a retained reagent kit lot 49156ud00.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 lot 49156ud00 performs as expected for this product.Ticket trending review did not identify any related trends.Device history review did not identify any non-conformances or deviations with the lot 49156ud00 and the complaint issue.In-house accuracy testing was completed with retained kit of lot 49156ud00 using panels which mimic patient samples.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the creatinine2 reagent lot 49156ud00 was identified.

Event Description

The customer observed a falsely elevated creatinine2 result generated on the architect c4000 processing module for one sample.The following data was provided: (b)(6)2023 sid (b)(6)initial result = 8.53 mg/dl the patient was retested at another hospital = 0.92 mg/dl the quality controls shifted up but was within range for level 1 and 3.Level 2 was out of range high.No impact to patient management was reported.

• Brand Name: CREATININE2
• Type of Device: 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: 18073304
• MDR Text Key: 327400879
• Report Number: 3005094123-2023-00300
• Device Sequence Number: 1
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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: 12/15/2023

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 Expiration Date: 04/18/2024
• Device Catalogue Number: 04S95-20
• Device Lot Number: 49156UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4 PROC MOD, 02P24-01, C461903