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	08/08/2023
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 initially reported problems with the total bilirubin qc on an architect analyzer and then further reported that they had issues with result for a pediatric patient when changing to a new reagent lot and provided the following data: customer normal range for total bilirubin was 0.2 to 1.2 mg/ml and for direct bilirubin was 0.1 to 0.3 mg/ml.The initial result generated from the new lot was 16.The sample was repeated after the assay was recalibrated with a new calibrator and generated a result of 11.The customer reported that the analyzer that was routinely used generated a total bili of 12 and direct bili of 0.4 and the emergent analyzer generated a total bili of 9.07 and direct bili of 0.32.It was further reported that during a performance test the calibrator required to be reconfigured.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation for the total bilirubin quality control results shift low after changing to new bilirubin calibrator, lot number 97447fd01 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 yet 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 there is not an increase in complaint activity for the complaint lot.Ticket trending review did not identify any trends regarding commonalities for complaint lot.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 was identified.Corrected information in section: g1-contact office first name.G1-contact office last name.G1-contact office address 1.G1-contact office city.G1-contact office zip code.G1-contact office country.G1-contact office phone number.G1-contact office email.G1-contact office fax number.
Event or Problem Description
The customer initially reported problems with the total bilirubin qc on an architect analyzer and then further reported that they had issues with result for a pediatric patient when changing to a new reagent lot and provided the following data: customer normal range for total bilirubin was 0.2 to 1.2 mg/ml and for direct bilirubin was 0.1 to 0.3 mg/ml.The initial result generated from the new lot was 16.The sample was repeated after the assay was recalibrated with a new calibrator and generated a result of 11.The customer reported that the analyzer that was routinely used generated a total bili of 12 and direct bili of 0.4 and the emergent analyzer generated a total bili of 9.07 and direct bili of 0.32.It was further reported that during a performance test the calibrator required to be reconfigured.There was no reported impact to patient management.

• 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: 17650647
• Report Number: 3002809144-2023-00374
• Device Sequence Number: 12326489
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 12/11/2023

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: 05/31/2024
• Device Catalogue Number: 06L45-22
• Device Lot Number: 63297UQ12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2024
• 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) ; CC BILIRUBIN CAL, 01E66-04, (B)(6) ; CC BILIRUBIN CAL, 01E66-04, (B)(6)
• Patient Sex: Unknown