MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CREATININE

Model Number	3L81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2019
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely increased creatinine result generated on the architect c4000 analyzer on one patient.Results provided: (b)(6) 2019 sid (b)(6) = 3.27 / 3.27 mg/dl; new sample collected = 0.94 / 0.89 mg/dl.Other results provide: bun = 11 mg/dl on both samples.No impact to patient management was reported.
Additional Manufacturer Narrative
The customer acknowledges issue was sample specific with the initial draw.No customer returns were available for evaluation.A review of ticket trending for architect creatinine reagent product lot number (88664un18) did not find any atypical complaint trends identified.The trend review by the product list number (3l81) found no trends related to this issue.Labeling, including sample handling procedures was reviewed and found to adequately address the issue under review.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.No product deficiency was identified.

• Brand Name: CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9259538
• Report Number: 1628664-2019-00691
• Device Sequence Number: 14090929
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 01/20/2020

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: 06/17/2020
• Device Model Number: 3L81-22
• Device Catalogue Number: 03L81-22
• Device Lot Number: 88664UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/20/2020
• 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 LIST 02P24-40; ARCHITECT C4000 ANALYZER LIST 02P24-40; SERIAL (B)(6); SERIAL (B)(6)