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

Model Number 3L81-33

Device Problem High Test Results (2457)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated creatinine results generated on the architect c16000 processing module for one patient with allergic shock and cortisol administration.The following data was provided: (b)(6) 2022 sid (b)(6) initial result was 29.95 mg/dl, repeated 29.95 mg/dl.A new sample was drawn sid (b)(6) and the results were 0.65 and 0.63 mg/dl.No adverse impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined there is normal complaint activity for lot number 09280un22.Return testing was not performed as returns were not available.Device history record review was performed on lot 09280un22, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.File sample analysis was not performed as fresh sample when redrawn and retested, generated lower result.Quality control was in range.No additional issues were identified.Labeling was reviewed and was found to adequately address the issue under review.Based on all reviewed data, we conclude that there is no product deficiency with the architect creatinine reagent identified in this complaint.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

• 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: 15324395
• MDR Text Key: 301094549
• Report Number: 3002809144-2022-00311
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740161569
• UDI-Public: 00380740161569
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083809
• 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: 09/20/2022

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: 3L81-33
• Device Catalogue Number: 03L81-33
• Device Lot Number: 09280UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, (B)(6).; ARC C16K PRC MOD, 03L77-01, (B)(6).