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

Model Number	3L81-33
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer observed falsely elevated creatinine result on architect c8000 processing module for one transplant patient.The results provided were: on (b)(6) 2021 sid (b)(6) initial creatinine=10.6 mg/dl /repeated on (b)(6) 2021=1.5 mg/dl.Laboratory reference range for creatinine=0.6 mg/dl to 1.1 mg/dl.The patient was admitted into hospital and physician performed procedures on patient due to falsely elevated creatinine result.There was no additional information provided by customer regarding treatment or medication for patients.There was no additional impact to patient management reported.
Additional Manufacturer Narrative
A review of complaints for architect creatinine reagent lot 07255un20 identified only current complaint for creatinine results.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect creatinine reagent lot, 07255un20.
Additional Manufacturer Narrative
Additional manufacture narrative: a review of complaints for architect creatinine reagent lot 07255un20 identified only current complaint for creatinine results.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect creatinine reagent lot, 07255un20.In addition, as part of the investigation, a cross functional team (cft) reviewed the complaint and determined the architect creatinine assay was being used per the intended use of the assay.The patient had elevated architect creatinine results which determined the treatment of the patient.As the customer used the assay correctly, a risk evaluation was initiated.During the risk evaluation, the cft performed a reviewed the risk management file and concluded the risk management file is adequate and no updates are needed.

• Brand Name: CREATININE
• Common Device Name: 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 11303137
• Report Number: 3002809144-2021-00094
• Device Sequence Number: 3368800
• Product Code: CGX
• UDI-Device Identifier: 00380740161569
• UDI-Public: 00380740161569
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2021
• Device Model Number: 3L81-33
• Device Catalogue Number: 03L81-33
• Device Lot Number: 07255UN20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 02/18/2021; 01/29/2024
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/23/2021; 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2020
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C8 PROC MOD, 01G06-11, (B)(6) ; ARC C8 PROC MOD, 01G06-11, (B)(6) ; ARC C8 PROC MOD, 01G06-11, (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown