MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Catalog Number 03L81-22

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8683450
• MDR Text Key: 147616965
• Report Number: 1628664-2019-00432
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (y/n): N
• PMA/PMN Number: K981799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER; LN 02P24-40, SN (B)(4)