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

Model Number	6L45-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
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.
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect c8000 processing module for multiple newborn patients.The results of the total bilirubin didn¿t match the degree of neonatal jaundice.The samples were repeated with siemens¿ instrumentation and abbott¿s results were 20-30% higher.The following example data was provided: sample 1: architect result = 339 umol/l, siemens¿ result = 264 umol/l.Sample 2: architect result = 180 umol/l, siemens¿ result = 146 umol/l.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated total bilirubin results generated on the architect c8000 processing module for multiple newborn patients.The results of the total bilirubin didn¿t match the degree of neonatal jaundice.The samples were repeated with siemens¿ instrumentation and abbott¿s results were 20-30% higher.The following example data was provided: sample 1: architect result = 339 umol/l, siemens¿ result = 264 umol/l sample 2: architect result = 180 umol/l, siemens¿ result = 146 umol/l no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated total bilirubin results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any nonconformances or deviations associated with lot number 37197fd01 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In this case, the on-site data reviewed found recent assay calibration curve significantly differed from the previous calibration curve of the same lot number.Quality control values are relatively low.The customer confirmed the calibrator had been opened for a relatively long period of time which might have caused the calibrator to deteriorate.When switched to a new calibrator and recalibrated, calibration curve improved significantly.Based on the investigation total bilirubin calibrator lot 37197fd01 is performing as intended, no systemic issue or deficiency of the total bilirubin calibrator was identified.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16497641
• Report Number: 3016438761-2023-00123
• Device Sequence Number: 6316393
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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: 09/30/2023
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 61879UQ04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC C8000 PRC MOD, 01G06-01, (B)(6).; ARC C8000 PRC MOD, 01G06-01, (B)(6).; CC BILIRUBIN CAL(6X5ML), 01E66-05, (B)(6).
• Patient Sex: Unknown