MAUDE Adverse Event Report: ABBOTT LABORATORIES 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
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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 labcorp 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.
Additional Manufacturer Narrative
An error was identified on jan 14, 2019.The manufacturer location in this submission is incorrect and has been updated and all follow up information will be contained in manufacturer report number 1628664-2019-00023.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8126516
• Report Number: 1415939-2018-00164
• Device Sequence Number: 10830092
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 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 Catalogue Number: 03L81-22
• Device Lot Number: 75410UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement 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
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C4000, LIST 02P24-01; ARCHITECT C4000, LIST 02P24-01; SERIAL (B)(4); SERIAL (B)(4)
• Patient Age: 63 YR