MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

Catalog Number	06L45-41
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
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.There is no further patient information provided by the customer.
Event or Problem Description
The customer reported falsely depressed total bilirubin results on 44 patients generated on the architect analyzer.The customer reported a result of <0.1mg/dl; then during her lunch another tech had 2 more result <0.1 and questioned them.They replaced the kit and retested the three samples with all generating 0.2 (0.3-1.2mg/dl).The customer then repeated all remaining 44 samples from (b)(6) 2019 between 07:00 to 13:30, results ranged from 0.1 to 1.0.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets by lot 53194uq06, found no other complaints similar to the current complaint and no trends were identified related to this issue.Return testing was not completed as returns were not available.Historical performance of reagent lot 53194uq06 was evaluated using world wide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 53194uq06 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 53194uq06.A review of product labeling found adequate information regarding sample handling, interpretation of results, and troubleshooting of this issue.Based on the investigation no product deficiency was identified for the clinical chemistry total bilirubin assay, lot 53194uq06.

• Brand Name: CLINICAL CHEMISTRY TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8405229
• Report Number: 1628664-2019-00185
• Device Sequence Number: 11344582
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K060574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 11/30/2019
• Device Catalogue Number: 06L45-41
• Device Lot Number: 53194UQ06
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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, LIST # 01G06-11,; ARCHITECT C8000 SYSTEM, LIST # 01G06-11,; SERIAL # (B)(4); SERIAL # (B)(4)