MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CREATININE

Catalog Number	03L81-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false elevated creatinine result when processing on the architect c16000.The initial result on (b)(6) was 4.86 mg/dl and retest results were 1.03, 1.00, and 1.02.Retest on another analyzer was 0.94 mg/dl.No impact to patient management was reported.
Additional 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 by product lot number found no other tickets similar to this issue.The trend review did not identify any trends related to the issue.Returns were not available from the customer for this investigation.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9162101
• Report Number: 1628664-2019-00651
• Device Sequence Number: 2062514
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K981799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2020
• Device Catalogue Number: 03L81-32
• Device Lot Number: 07559UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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 ANALYZER; LN 03L77-01 SN (B)(4)