MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CREATININE

Catalog Number	03L81-32
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, device history review, and log review.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Device history review did not identify any issues that may have caused the customer issue.Log review showed multiple occurrences of aspiration errors and cuvette washing not completed errors.Review of the analyzer maintenance log showed the wash cuvettes procedure was not performed as instructed per the operations manual after every occurrence of the cuvette wash errors.Review additionally showed that maintenance had not been performed as recommended in the architect operations manual, and may have contributed to the customer issue.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.
Event or Problem Description
The customer stated that a patient had falsely elevated creatinine results generated using the clinical chemistry creatinine reagents.The following data was provided in mg/dl.Initial 4.59.Repeat results using a sample from the same patient showed normal results, however no specific values were provided for the repeat tests.Normal range is less than 1.25.No impact to patient management was reported.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6593013
• Report Number: 1628664-2017-00234
• Device Sequence Number: 13691675
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 05/25/2017

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: 02/07/2017
• Device Catalogue Number: 03L81-32
• Device Lot Number: 14625UN15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1