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

Model Number	6L45-42
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed total bilirubin results after a new wedge was put on the instrument.The customer noticed it when they started to get less than results on their patients.They recalibrated the assay and ran qc and qc came within range; they reran their patients and got actual results other than less than and had to make corrected reports.The following data was provided (patient reference range 0.2 - 1.3 mg/dl): sample id original result repeat result: (b)(6) 0.19 0.71, (b)(6) 0.1 0.23, (b)(6) 0.1 0.43, (b)(6) 0.65 1.14, (b)(6) 0.1 0.51, (b)(6) 0.1 0.32, (b)(6) 0.1 0.36, (b)(6) 0.1 0.36, (b)(6) 0.1 0.54, (b)(6) 0.1 0.3, (b)(6) 0.55 1.08, (b)(6) 0.1 0.45, (b)(6) 0.31 0.82, (b)(6) 0.1 0.3, (b)(6) 0.1 0.33, (b)(6) 0.24 0.75, (b)(6) 0.1 0.51, (b)(6) 0.12 0.62, (b)(6) 0.1 0.54, (b)(6) 0.1 0.63, (b)(6) 0.57 1.05, (b)(6) 0.1 0.26, (b)(6) 0.1 0.5, (b)(6) 0.1 0.28, (b)(6) 0.14 0.62, (b)(6) 0.33 0.85, (b)(6) 0.7 0.56, (b)(6) 0.5 0.39, (b)(6) 1.2 1.71, (b)(6) 0.4 0.25, (b)(6) 0.18 0.71, (b)(6) 0.34 0.85, (b)(6) 0.6 0.45, (b)(6) 0.5 0.38, (b)(6) 0.7 0.54, (b)(6) 0.1 0.42, (b)(6) 0.3 0.19, (b)(6) 0.1 0.45, (b)(6) 1 1.38, (b)(6) 0.2 0.49, (b)(6) 0.1 0.37, (b)(6) 0.3 0.65, (b)(6) 0.2 0.56, (b)(6) 0.9 1.27, (b)(6) 0.1 0.43, (b)(6) 0.2 0.51, (b)(6) 0.2 0.57, (b)(6) 0.6 0.95, (b)(6) 0.2 0.55, (b)(6) 0.5 0.89, (b)(6) 0.1 0.47, (b)(6) 0.1 0.38, (b)(6) 0.6 0.96, (b)(6) 0.6 0.96, (b)(6) 0.2 0.52, (b)(6) 0.2 0.49, (b)(6) 0.8 1.15.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.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed.Return testing was not performed as returns were not available.Device history record review was performed on lot 61824uq03, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.To further investigate the customer¿s issue, the historical performance of reagent lot 61824uq03 was evaluated using world-wide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 61824uq03 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 61824uq03.User error may have contributed to issue of generating patient results below the assay linearity after installing a new reagent cartridge as the reagent package insert states the reagents are susceptible to the formation of foam and bubbles that may interfere with proper detection of reagent level in the cartridge, causing insufficient reagent aspiration which could impact results.Review of product labeling found adequate information regarding the issue under review.Based on the investigation, no systemic issue or deficiency of the total bilirubin assay 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: 16133583
• Report Number: 3002809144-2023-00023
• Device Sequence Number: 7607980
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: 00380740174972
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 02/21/2023

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: 08/31/2023
• Device Model Number: 6L45-42
• Device Catalogue Number: 06L45-42
• Device Lot Number: 61824UQ03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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 C4000 INTGR, 02P24-40, (B)(6); ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Unknown