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

Catalog Number	06L45-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed quality control values shifted downward but still within range when using the cc bilirubin assay on the architect c4000 processing module.The customer stated they are repeating patient samples that generated a falsely decreased result of < 0.1 mg/dl and the customer has been seeing a change in repeat patient results.The customer was rerunning the samples on the same analyzer using fresh reagent and quality control.The following data was provided: sample id (b)(6): previous result = < 0.1 mg/dl; repeat result = 0.2 mg/dl.Sample id (b)(6): previous result = < 0.1 mg/dl; repeat result = 0.3 mg/dl.Sample id (b)(6): previous result = <0.1 mg/dl; repeat result = 0.2 mg/dl.Sample id (b)(6): previous result = < 0.1 mg/dl; repeat result = 0.2 mg/dl.Sample id (b)(6): previous result = < 0.1 mg/dl; repeat result = 0.2 mg/dl.Sample id (b)(6): previous result = < 0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6): previous result = < 0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6): previous result = < 0.1 mg/dl repeat result = 0.2 mg/dl.Sample id (b)(6): previous result = < 0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6): previous result = <0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6): previous result = < 0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6): previous result = < 0.1 mg /dl; repeat result = 0.1 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6): ,(b)(6), (b)(6), (b)(6), (b)(6) (12 patients in total).All available patient information was included.Additional patient details are not available.Section g1 contact information was updated to reflect the current contact (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation 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 without indication for any additional issue.A ticket search by lot did not identify an increase in complaint activity for the current issue.The ticket trending review did not identify any related trends for the product for the issue.Review of the device history record found no issue related to the current complaint.As part of troubleshooting, the customer reran samples on the same analyzer using fresh reagent and qc.The reagent was recalibrated.Issue was resolved after calibration.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency with the total bilirubin reagent lot 63648uq02 was identified.
Event or Problem Description
The customer observed quality control values shifted downward but still within range when using the cc bilirubin assay on the architect c4000 processing module.The customer stated they are repeating patient samples that generated a falsely decreased result of < 0.1 mg/dl and the customer has been seeing a change in repeat patient results.The customer was rerunning the samples on the same analyzer using fresh reagent and quality control.The following data was provided: sample id (b)(6) : previous result = < 0.1 mg/dl; repeat result = 0.2 mg/dl.Sample id (b)(6) : previous result = < 0.1 mg/dl; repeat result = 0.3 mg/dl.Sample id (b)(6) : previous result = <0.1 mg/dl; repeat result = 0.2 mg/dl.Sample id (b)(6) : previous result = < 0.1 mg/dl; repeat result = 0.2 mg/dl.Sample id (b)(6) : previous result = < 0.1 mg/dl; repeat result = 0.2 mg/dl.Sample id (b)(6) : previous result = < 0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6) : previous result = < 0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6) : previous result = < 0.1 mg/dl repeat result = 0.2 mg/dl.Sample id (b)(6) : previous result = < 0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6) : previous result = <0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6) : previous result = < 0.1 mg/dl; repeat result = 0.1 mg/dl.Sample id (b)(6) : previous result = < 0.1 mg /dl; repeat result = 0.1 mg/dl.There was no impact to patient management reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17901071
• Report Number: 3002809144-2023-00424
• Device Sequence Number: 15198622
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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: 07/31/2024
• Device Catalogue Number: 06L45-22
• Device Lot Number: 63648UQ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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 C4 PROC MOD, 02P24-01, (B)(6) ; ARC C4 PROC MOD, 02P24-01, (B)(6)
• Patient Sex: Unknown