MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC 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	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: multiple = sid (b)(6) and 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 the architect analyzer for one patient.The results provided were: sid (b)(6) on (b)(6) 2018 = 25.86mg/l (2.59mg/dl)/ repeat = 25.36mg/l (2.54mg/dl) / repeated on (b)(6) 2018 = 24.23mg/l (2.42mg/dl) / sample sent to another site with an architect and the result was normal.The patient returned on (b)(6) 2019, sid (b)(6) = 7.14mg/l (0.71mg/dl) / 6.93mg/l (0.69mg/dl).There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets for lot 64131un18 found one additional complaint but no trends were identified for similar issues.Return testing was not completed as returns were not available.Using worldwide data through abbottlink, the historical performance of lot 64131un18 was compared to the performance of all architect creatinine reagent lots in the field.The patient median was analyzed and found no significant difference in performance compared to historical performance.Based on this review, no unusual performance issues were identified with reagent lot 64131un18.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Abbott was unable to determine a definitive cause for the customer's issue; however, the architect system operations manual contains potential causes and corrective actions for elevated and erratic results; including: debris in the water bath, dirty cuvettes, and handling and preparation of the sample.Based on the investigation no product deficiency was identified for the clinical chemistry creatinine, lot 64131un18.

• Brand Name: CLINICAL CHEMISTRY CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8355748
• Report Number: 1628664-2019-00150
• Device Sequence Number: 11294267
• Product Code: CGX
• UDI-Device Identifier: 00380740005979
• UDI-Public: 00380740005979
• 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): 04/29/2019

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?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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 01G06-01; ARCHITECT C8000 SYSTEM, LN 01G06-01,; SERIAL # C800940; SERIAL # C800940