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
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated creatinine results on the architect c4000 analyzer.The following data was provided: sid (b)(6) initial 2.91, repeat 0.87, 0.87 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
During the investigation, the customer's instrument logs were reviewed around the timeframe of the incident.It was noted that although the customer's controls were within the expected range flags were associated with the quality control indicating that a component was expired.Further review found the creatinine calibration was expired, and the customer was using an expired component on the analyzer, bulk solution, and wash solution.A review of the complaint tracking and trending database was performed, which found no complaint trends associated with the creatinine reagent.Field data was reviewed to assess the performance of the reagent lot; the median patient result for lot 64131un18 was within established baselines.Manufacturing documentation was reviewed and no issues were identified.Additionally, labeling was reviewed and adequately addresses the customer issue.Based on the investigation, no systemic issues or product deficiency was identified for the creatinine reagent.

• Brand Name: CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8497343
• Report Number: 1628664-2019-00292
• Device Sequence Number: 13766577
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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: 11/22/2019
• Device Catalogue Number: 03L81-22
• Device Lot Number: 64131UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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 ANALYZER; ARCHITECT C4000 ANALYZER; LN 02P24-01 SN (B)(4); LN 02P24-01 SN (B)(4)