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	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely depressed total bilirubin results for 14 patient samples while running on the architect c4000 processing module.The customer stated there were 50 tests left in the total bilirubin reagent kit and the samples gave results of 0.10 mg/dl.The customer reports out linearity for this assay as an actual result.The customer noticed the trend on the values being generated and moved the testing to a second reagent kit already loaded on board.The kit that was in use that generated the discrepant results was discarded by the customer.All 14 samples when tested with the new total bilirubin reagent kit gave an actual value when repeated.The customer issued 14 amended reports to the providers.The following data was provided (normal range: 0.2-1.2 mg/dl - unit of measure: mg/dl) sample 1: initial result = < 0.10 / repeat result = 0.31, sample 2: initial result = < 0.10 / repeat result = 0.37, sample 3: initial result = < 0.10 / repeat result = 0.29, sample 4: initial result = < 0.10 / repeat result = 0.45, sample 5: initial result = < 0.10 / repeat result = 0.35, sample 6: initial result = < 0.10 / repeat result = 0.44, sample 7: initial result = < 0.10 / repeat result = 0.40, sample 8: initial result = < 0.10 / repeat result = 0.36, sample 9: initial result = < 0.10 / repeat result = 0.34, sample 10: initial result = < 0.10 / repeat result = 0.30, sample 11: initial result = < 0.10 / repeat result = 0.30, sample 12: initial result = < 0.10 / repeat result = 0.38, sample 13: initial result = < 0.10 / repeat result = 0.15 and sample 14: initial result = <0.10 / repeat result = 0.34.There was no impact to patient management reported.
Event or Problem Description
The customer reported falsely depressed total bilirubin results for 14 patient samples while running on the architect c4000 processing module.The customer stated there were 50 tests left in the total bilirubin reagent kit and the samples gave results of < 0.10 mg/dl.The customer reports out < linearity for this assay as an actual result.The customer noticed the trend on the values being generated and moved the testing to a second reagent kit already loaded on board.The kit that was in use that generated the discrepant results was discarded by the customer.All 14 samples when tested with the new total bilirubin reagent kit gave an actual value when repeated.The customer issued 14 amended reports to the providers.The following data was provided (normal range: 0.2-1.2 mg/dl - unit of measure: mg/dl).Sample 1: initial result = < 0.10 / repeat result = 0.31.Sample 2: initial result = < 0.10 / repeat result = 0.37.Sample 3: initial result = < 0.10 / repeat result = 0.29.Sample 4: initial result = < 0.10 / repeat result = 0.45.Sample 5: initial result = < 0.10 / repeat result = 0.35.Sample 6: initial result = < 0.10 / repeat result = 0.44.Sample 7: initial result = < 0.10 / repeat result = 0.40.Sample 8: initial result = < 0.10 / repeat result = 0.36.Sample 9: initial result = < 0.10 / repeat result = 0.34.Sample 10: initial result = < 0.10 / repeat result = 0.30.Sample 11: initial result = < 0.10 / repeat result = 0.30.Sample 12: initial result = < 0.10 / repeat result = 0.38.Sample 13: initial result = < 0.10 / repeat result = 0.15.Sample 14: initial result = <0.10 / repeat result = 0.34.There was no impact to patient management reported.
Additional Manufacturer Narrative
Updated d4 - primary udi number.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.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the total bilirubin reagent lot 64314uq05 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18924824
• Report Number: 3002809144-2024-00076
• Device Sequence Number: 4540942
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: (01)00380740174965(17)241031(10)64314UQ05
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 05/16/2024

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: 10/31/2024
• Device Catalogue Number: 06L45-22
• Device Lot Number: 64314UQ05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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 C4000 INTGR, 02P24-40, (B)(6) ; ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Unknown