MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CREATININE

Catalog Number	03L81-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a, patient information, patient identifier sid (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.
Event or Problem Description
The customer reported falsely elevated creatinine results on one patient on the architect analyzer.The results provided were: sid (b)(6) on (b)(6) 2019 creatinine = 793 / 762 / 753umol/l; new sample on (b)(6) 2019 creat = 96.9umol/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets found one similar complaint for creatinine lot 03282un18, but no trends were identified for falsely elevated results.Return testing was not completed as returns were not available.Historical performance of reagent lot 03282un18 was evaluated using world wide data from abbottlink.The population median results for the lot are within established limits.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed and multiple probable causes were identified: unperformed maintenance on the instrument or pre-analytical sample handling issues.Based on the investigation no product deficiency was identified for the clin chem creatinine reagent, lot 03282un18.

• Brand Name: CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8594909
• Report Number: 1628664-2019-00362
• Device Sequence Number: 1666794
• Product Code: CGX
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 01/20/2020
• Device Catalogue Number: 03L81-32
• Device Lot Number: 03282UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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 C8000 SYSTEM: LN 01G06-11:.; ARCHITECT C8000 SYSTEM: LN 01G06-11:.; SERIAL # (B)(4).; SN (B)(4).; ARCHITECT C8000 SYSTEM: LN 01G06-11:; SN (B)(4)