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

Model Number	6L45-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).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 decreased total bilirubin results generated on the architect c8000 analyzer for multiple patient samples.The customer repeated the samples on another instrument which generated higher results.The following data was provided: normal range is 0.3 to 1.2 mg/dl patient a initial result = < 0.1 mg/dl, repeat result (c803623) = 0.2 mg/dl, previous result (5 days prior) = 0.9 mg/dl.Patient b initial result = < 0.1 mg/dl, repeat result (c803623) = 0.2 mg/dl, no previous result patient 1 initial result =0.6 mg/dl, repeat result (c803623) = 0.8 mg/dl patient 2 initial result = 0.5 mg/dl, repeat result (c803623) = 0.7 mg/dl patient 3 initial result = <0.1 mg/dl, repeat result (c803623) = 0.2 mg/dl patient 4 initial result = 0.2 mg/dl, repeat result (c803623) = 0.4 mg/dl patient 5 initial result = 0.1 mg/dl, repeat result (c803623) = 0.3 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased 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.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 60977uq01 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.The customer¿s instrument history log was reviewed and multiple aspiration errors on samples and reagent were identified.The most likely cause of the erratic results for total bilirubin may be hardware issues corrected during troubleshooting or recalibration of the assay.Based on our investigation, no systemic issue or deficiency with the total bilirubin assay for lot 60977uq01 was identified.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15256281
• Report Number: 3002809144-2022-00290
• Device Sequence Number: 6636063
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2022

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: 06/30/2023
• Device Model Number: 6L45-22
• Device Catalogue Number: 06L45-22
• Device Lot Number: 60977UQ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 10/26/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/19/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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 C8 PROC MOD, 01G06-11, (B)(4); ARC C8 PROC MOD, 01G06-11, (B)(4); ARC C8 PROC MOD, 01G06-11, (B)(4)
• Patient Sex: Unknown