MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Catalog Number	03L81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
A physician questioned a falsely elevated architect creatinine result of 2.99 mg/dl (sid (b)(6)).A new sample was collected from the same patient (sid (b)(6)) and the architect creatinine result was 0.87 mg/dl.Both samples were retested and results were 1.12 and 0.85 mg/dl respectively.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
A review of all complaints associated with the creatinine assay and a review of tracking and trending for the list number was performed.The review did not identify any trends associated with this issue.Additionally, labeling was reviewed and adequately addresses the customer issue.Based on the investigation, no systemic issue or deficiency was identified for the creatinine assay.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8688244
• Report Number: 1628664-2019-00439
• Device Sequence Number: 2349686
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K981799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: 04/15/2020
• Device Catalogue Number: 03L81-22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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: ARCHITECT C4000 ANALYZER; LN 02P24-40, SN (B)(4)