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 Type  malfunction  

Manufacturer Narrative

All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false elevated creatinine result when processing on the architect c8000.The initial result was 10.98 and retest result was 0.98.The customer uses a reference range of 0.72-1.25 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, and a review of product labeling.A search for similar tickets by lot number revealed only the current complaint ticket.A review of the lot search did not identify an increase in complaint activity.A review of the trending data did not identify any trends.Return testing was not completed as returns were not available.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

Manufacturer Narrative

This follow-up report is being submitted to update the suspect medical device lot number from unknown to lot 20993un19, which was identified on 17dec2019.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• Brand Name: CREATININE
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9458141
• MDR Text Key: 206842671
• Report Number: 1628664-2019-00757
• 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,Followup
• Report Date: 02/11/2020

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: 08/13/2020
• Device Model Number: 3L81-22
• Device Catalogue Number: 03L81-22
• Device Lot Number: 20993UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 01/17/2020
• Supplement Dates FDA Received: 01/13/2020; 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000, LIST 01G06-11; SERIAL (B)(6)