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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of complaint test, historical complaints and product labeling.No adverse trend was identified for the customer's issue.Review of the complaint activity determined that there was no increase identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostic's complaint investigation, no product deficiency was identified.Note: this information was previously reported in manufacturer report 1415939-2018-00164 against the incorrect manufacturing site.
Event or Problem Description
The customer observed multiple falsely elevated architect creatinine results from a patient sample.The initial result was 6.72 mg/dl and repeat results (same instrument) were 6.72 and 6.63 mg/dl.The customer uses a reference range of 0.57-1.25 mg/dl.As a result, the patient was sent for a redraw and repeat testing was normal (no specific result provided).No other impact to patient management was reported.The customer reported there were no issues with sample collection/handling nor with sample integrity and that other assays were performed on the same sample without any issue.An aliquot of the original sample was sent to (b)(6) for testing (cobas 710 instrument, creatinine jaffe method) and yielded a result of 2.646.Additional testing (ex.Bun) correlated with the creatinine redraw normal result, patient history and previously reported results.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8245463
• Report Number: 1628664-2019-00023
• Device Sequence Number: 2462852
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 01/14/2019

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: 05/13/2019
• Device Catalogue Number: 03L81-22
• Device Lot Number: 75410UN17
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2018
• Initial Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR