MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Model Number	3L81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation in process.
Event or Problem Description
The account generated a falsely elevated architect creatinine results of 2.25 and 2.20 mg/dl on a sample that tested beckman au480 creatinine method of 1.17 mg/dl.The sample was obtained after thombolysis treatment.The pre-treatment sample generated architect creatinine of 1.33 mg/dl and beckman enzymatic method of 1.39 mg/dl.No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of all complaints associated with the creatinine assay, lot number 82313un16, and a review for complaint trends for the list number was performed.The review did not identify any trends associated with this issue.Additionally, labeling was reviewed and adequately addresses the issue under review.Based on this information, no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6557029
• Report Number: 1628664-2017-00201
• Device Sequence Number: 11046422
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: (01)00380740005979(17)171227(10)82313UN16
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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: 12/27/2017
• Device Model Number: 3L81-22
• Device Catalogue Number: 03L81-22
• Device Lot Number: 82313UN16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 07/23/2017
• 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: (B)(4); (B)(4).