MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Catalog Number 03L81-22

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8688244
• MDR Text Key: 148071188
• Report Number: 1628664-2019-00439
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (y/n): N
• PMA/PMN Number: K981799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2020
• Device Catalogue Number: 03L81-22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER; LN 02P24-40, SN (B)(4)