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

Model Number 6L45-22

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 305524727
• Report Number: 3002809144-2022-00290
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/06/2022; 10/26/2022
• Supplement Dates FDA Received: 09/19/2022; 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, (B)(4); ARC C8 PROC MOD, 01G06-11, (B)(4); ARC C8 PROC MOD, 01G06-11, (B)(4)