MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CREATININE

Model Number 3L81-32

Device Problem High Test Results (2457)

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

Event Date 10/20/2019

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 observed a falsely elevated creatinine result generated on the architect c16000 for 1 sample.The following data was provided: (b)(6) initial result = 233 umol/l, new sample was collect = 55 umol/l, original sample was repeat = 66 umol/l.

Manufacturer Narrative

A review of tickets and testing for the likely cause lot could not be performed since the likely cause lot is unknown.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of tracking and trending for the creatinine reagent found no unusual variations.A review of manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the creatinine reagent was identified.

• Brand Name: CREATININE
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9329185
• MDR Text Key: 169081338
• Report Number: 1628664-2019-00718
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• 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: 02/12/2020

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 Model Number: 3L81-32
• Device Catalogue Number: 03L81-32
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 PROCESSING MODULE, LIST 03L77-01; SERIAL (B)(4).