MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CREATININE

Model Number 3L81-22

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer reported a falsely increased creatinine result generated on the architect c4000 analyzer on one patient.Results provided: (b)(6) 2019 sid (b)(6) = 3.27 / 3.27 mg/dl; new sample collected = 0.94 / 0.89 mg/dl.Other results provide: bun = 11 mg/dl on both samples.No impact to patient management was reported.

Manufacturer Narrative

The customer acknowledges issue was sample specific with the initial draw.No customer returns were available for evaluation.A review of ticket trending for architect creatinine reagent product lot number (88664un18) did not find any atypical complaint trends identified.The trend review by the product list number (3l81) found no trends related to this issue.Labeling, including sample handling procedures was reviewed and found to adequately address the issue under review.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.No product deficiency was identified.

• Brand Name: CREATININE
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9259538
• MDR Text Key: 195148733
• Report Number: 1628664-2019-00691
• 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: 01/20/2020

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: 06/17/2020
• Device Model Number: 3L81-22
• Device Catalogue Number: 03L81-22
• Device Lot Number: 88664UN18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER LIST 02P24-40; ARCHITECT C4000 ANALYZER LIST 02P24-40; SERIAL (B)(6); SERIAL (B)(6)