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

Model Number	3L81-23
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer questioned creatinine results generated with the architect c4000 processing module for one patient.The following was provided by the customer.Sid (b)(6) result 3.18 rerun 0.84 mg/dl.Customer had a renal panel under a different sid (sid (b)(6)) and result was close to the repeated result.Customer stated the result was corrected to 0.84 which matches patient history.Customer normal range 0.70-7.20 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
An investigation was performed for architect creatinine reagent list number 03l81-23, lot number 15046un21.Review of tickets was performed and did not reveal atypical increase in complaint activity.A review of tracking and trending did not identify any trends for the complaint issue.Review of the product quality history for the lot number using search of the corrective and preventive actions (capa) system did not identify issues associated with the customer¿s observation.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect creatinine reagent list number 03l81-23, lot number 15046un21 was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14290919
• Report Number: 3002809144-2022-00150
• Device Sequence Number: 14804845
• Product Code: CGX
• UDI-Device Identifier: 00380740161552
• UDI-Public: 00380740161552
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 05/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 3L81-23
• Device Catalogue Number: 03L81-23
• Device Lot Number: 15046UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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, C462245
• Patient Sex: Unknown