MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided and troubleshooting performed by the customer was reviewed.The customer repeated the sample on the same and alternate architect analyzer and obtained 0.8 mg/dl.In addition, the customer did precision studies using quality control material that met the package insert precision claim.The customer also performed 6052 wash cuvette maintenance, qc was within range and the assay is performing within assay insert claims.Ticket searches for lot 55733un18 did not identify any other complaints.Tracking and trending report review for the architect creatinine assay did not identify any trends associated with the complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect creatinine assay was identified.
Event or Problem Description
The customer reported a falsely elevated architect creatinine result.The sample generated an initial result of 14.6 mg/dl and retest on the original and alternate analyzer generated 0.8 mg/dl.No impact to patient management was reported.

• Brand Name: CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8524692
• Report Number: 1628664-2019-00313
• Device Sequence Number: 1899952
• 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): 04/17/2019

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: 04/15/2020
• Device Catalogue Number: 03L81-22
• Device Lot Number: 55733UN18
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1