MAUDE Adverse Event Report: ABBOTT GMBH CREATININE; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number 3L81-23

Device Problem High Test Results (2457)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

The customer reported a falsely elevated creatinine result for a patient sample while running on the archtiect c4000 processing module.The patient was transported to the emergency room due to the elevated creatinine result, however no known treatment was performed based on the result provided.Lab¿s reference range for creatinine: 0.7-1.25 mg/dl.The following data was provided: on (b)(6) 2022, sid (b)(6): initial result: 7.26 mmg/dl.Rerun on the same instrument: 0.79, 0.80 mg/dl.There was no impact to patient management reported.

Manufacturer Narrative

All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for falsely elevated creatinine results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.The lot search review did not identify an increase in complaint activity for the current issue.A review of tracking and trending did not identify any related trends for the product for complaint issue.A review of the device history records did not identify any non-conformances or deviations associated with the reagent lot number 45458un22 and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect creatinine reagent lot 45458un22 was identified.

• Brand Name: CREATININE
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15810879
• MDR Text Key: 307474547
• Report Number: 3002809144-2022-00400
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740161552
• UDI-Public: 00380740161552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

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: 07/12/2023
• Device Model Number: 3L81-23
• Device Catalogue Number: 03L81-23
• Device Lot Number: 45458UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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, C460320; ARC C4 PROC MOD, 02P24-01, C460320