MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CREATININE

Model Number	3L81-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9329185
• Report Number: 1628664-2019-00718
• Device Sequence Number: 345630
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K981799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 3L81-32
• Device Catalogue Number: 03L81-32
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C16000 PROCESSING MODULE, LIST 03L77-01; SERIAL (B)(4).