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	01/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased architect total bilirubin results for multiple samples when running on the architect c8000 processing module.The following sids were provided by the customer that generated initial results of < 0.1 mg/dl since (b)(6) 2023.The qc run right after and determined level 1 was out of range low and was not repeated.Level 1 qc once again was out of range low on (b)(6) 2023.All patient samples were re-tested on another architect c8000 and generated results within normal range.The customer immediately sent out corrected reports.The following repeat testing results were: patient repeat results (unit of measure: mg/dl) (b)(6) = 0.2, (b)(6) = 0.3, (b)(6) = 0.3, (b)(6) = 0.3, (b)(6) = 0.3, (b)(6) = 0.5, (b)(6) = 0.4, (b)(6)= 0.4, (b)(6) = 0.3, (b)(6) = 0.3.The customer¿s normal range for total bilirubin is 0.2-1.5 mg/dl.Through troubleshooting, the customer opened fresh calibrator, recalibrated the assay and ran qc.The qc is now on the mean for levels 1, 3, and the pediatric.No repeat testing on the analyzer after troubleshooting tasks were performed were provided by the customer.There was no impact to patient management reported.
Additional Manufacturer Narrative
Patient identifier: (b)(6).All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed total bilirubin results when calibrated with bilirubin calibrator on architect c 8000 processing module included a search for similar complaints, and the review of complaint text, trending data, labeling, field data, and device history records.Return testing was not performed as returns were not available.The lot search did not find abnormal complaint activity for lot 61824uq03 and lot 37197fd01.Trending review determined no related trends for the products for the issue.Review of the device history records did not identify any issue related to the current complaint for total bilirubin reagent lot 61824uq03 and bilirubin calibrator lot 37197fd01.The historical performance of reagent lot 61824uq03 was evaluated using world-wide data from customers in the field.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.Review of labeling adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for architect total bilirubin reagent lot 61824uq03 and bilirubin calibrator lot 37197fd01.
Event or Problem Description
The customer observed falsely decreased architect total bilirubin results for multiple samples when running on the architect c8000 processing module.The following sids were provided by the customer that generated initial results of < 0.1 mg/dl since (b)(6)2023.The qc run right after and determined level 1 was out of range low and was not repeated.Level 1 qc once again was out of range low on 16jan2023.All patient samples were re-tested on another architect c8000 and generated results within normal range.The customer immediately sent out corrected reports.The following repeat testing results were: patient repeat results (unit of measure: mg/dl) (b)(6)= 0.2; (b)(6)= 0.3; (b)(6)= 0.3; (b)(6)= 0.3; (b)(6)= 0.3; (b)(6)= 0.5; (b)(6)= 0.4; (b)(6)= 0.4; (b)(6)= 0.3; (b)(6)= 0.3.The customer¿s normal range for total bilirubin is 0.2-1.5 mg/dl.Through troubleshooting, the customer opened fresh calibrator, recalibrated the assay and ran qc.The qc is now on the mean for levels 1, 3, and the pediatric.No repeat testing on the analyzer after troubleshooting tasks were performed were provided by the customer.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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16281078
• Report Number: 3002809144-2023-00066
• Device Sequence Number: 20531020
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: 00380740174972
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 05/01/2023
• 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 C8 PROC MOD, 01G06-11, (B)(6).; ARC C8 PROC MOD, 01G06-11, (B)(6).; CC BILIRUBIN CAL(6X5ML), 01E66-05, (B)(6).; CC BILIRUBIN CAL(6X5ML), 01E66-05, (B)(6).
• Patient Sex: Unknown