MAUDE Adverse Event Report: ABBOTT LABORATORIES TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN

Model Number 6L45-21

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for architect total bilirubin reagent ln 6l45-21/lot number 56889uq02.Return testing was not completed as returns were not available.The tracking and trending review determined no trends were identified for discrepant patient results for the product.Worldwide data was reviewed and determined that the patient median result for total bilirubin reagent lot number 56889uq02 is within established control limits.Retesting of the samples gave expected normal results.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 was adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect total bilirubin reagent lot number 56889uq02 was identified.

Event Description

The customer reported false decreased total bilirubin results for 2 patient samples while running on the architect c8000 processing module.The following data was provided on (b)(6) 2020 (reference range: 0.2-1.2 mg/dl): sample 1 = initial = 0.13 mg/dl; repeat result = 0.74 mg/dl.Sample 2 = initial = <0.10 mg/dl; repeat result = 0.94 mg/dl there was no impact to patient management reported.

• Brand Name: TOTAL BILIRUBIN
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 10838627
• MDR Text Key: 230510681
• Report Number: 3016438761-2020-00299
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K121985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 56889UQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1