MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY 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	06/16/2018
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.Patient information: no further information is available.
Event or Problem Description
The customer reported a false elevated architect creatinine result.Sample (b)(6) generated an initial result of 7.4 mg/dl and repeat generated 0.9 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of all complaints associated with the creatinine assay (list number 3l81, lot number 79769un18) and a review for complaint trends for the list number was performed.The review did not identify any trends associated with this issue.Manufacturing documentation for the product was reviewed and did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and adequately addresses the complaint issue.No systemic issue or deficiency of the architect creatinine assay 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: 7642272
• Report Number: 1628664-2018-00250
• Device Sequence Number: 14044221
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: 08/05/2019
• Device Catalogue Number: 03L81-32
• Device Lot Number: 79769UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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 C8000 ANALYZER; ARCHITECT C8000 ANALYZER; LIST 01G06, SERIAL (B)(4); LIST 01G06, SERIAL (B)(4)