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 01/06/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that discrepant architect creatinine results of 5.66 and 0.84 mg/dl were generated for a (b)(6) female patient (sample id (b)(6)).No adverse impact to patient management was reported.

Manufacturer Narrative

A review of all complaints associated with the creatinine assay (list number 3l81, lot number 32869un18) and a review for complaint trends and capa for the list number was performed.The review did not identify any trends associated with this issue.Historical performance of the reagent lot was evaluated using world wide data from abbott link.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for this lot is within the established control limits which indicates that the lot is performing acceptably and comparable to other lots in the field.Additionally, labeling was reviewed and adequately addresses the issue under review.Based on the available information, no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8294407
• MDR Text Key: 136914444
• Report Number: 1628664-2019-00080
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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: 09/09/2019
• Device Catalogue Number: 03L81-22
• Device Lot Number: 32869UN18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 SYSTEM; ARCHITECT C8000 SYSTEM; LIST 01G06-11, SERIAL (B)(4). ; LIST 01G06-11, SERIAL (B)(4).