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	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated creatinine results generated on the architect c4000 processing module for one sample.The following data was provided: sid (b)(6) initial and repeat results = 7.76 mg/dl, a new sample was collected which generated an initial result of 0.854 mg/dl and repeat result of 0.887 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated creatinine results 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 field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 97127un21 and the complaint issue.The overall performance of creatinine was reviewed using field data from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot number 97127un21 is within the established control limits.Therefore, no unusual reagent lot performance was identified.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the creatinine reagent for lot 97127un21 was identified.
Event or Problem Description
The customer observed falsely elevated creatinine results generated on the architect c4000 processing module for one sample.The following data was provided: sid (b)(6) initial and repeat results = 7.76 mg/dl, a new sample was collected which generated an initial result of 0.854 mg/dl and repeat result of 0.887 mg/dl no impact to patient management was reported.

• 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: 14463356
• Report Number: 3002809144-2022-00172
• Device Sequence Number: 17269069
• Product Code: CGX
• UDI-Device Identifier: 00380740161552
• UDI-Public: 00380740161552
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2022

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: 12/17/2022
• Device Model Number: 3L81-23
• Device Catalogue Number: 03L81-23
• Device Lot Number: 97127UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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 C4000 INTGR, 02P24-40, C402703; ARC C4000 INTGR, 02P24-40, C402703
• Patient Sex: Unknown