MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Catalog Number	03L81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
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
A physician questioned a falsely elevated architect creatinine result of 2.254 mg/dl that retested at 1.144 and 1.152 mg/dl.The patient was redrawn and the creatinine result was 0.9 mg/dl.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
A search for similar complaints for the creatinine lot 72194un18 did not identify any similar complaints to the customers issue.Tracking and trending did not identify any trends associated.The performance of the likely cause to lot 72194un18 were investigated by completing a review for non-conformances, and deviations related to the likely cause lots.This review did not identify any non-conformances or deviations.Instrument logs were reviewed for the customer instrument.The quality control (qc) appears to be performing as expected during the time the complaint was registered indicating the reagent was performing as expected at that time.No customer returns were available for evaluation.Review of product labeling found adequate information regarding the issue.Based on the investigation, no systemic issue or 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: 8683450
• Report Number: 1628664-2019-00432
• Device Sequence Number: 2207279
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 08/23/2019

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: 05/26/2020
• Device Catalogue Number: 03L81-22
• Device Lot Number: 72194UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 08/23/2019
• 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 C4000 ANALYZER; LN 02P24-40, SN (B)(4)