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

Model Number	6L45-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased architect total bilirubin results after installing a new reagent cartridge (same lot number but new cartridge) on (b)(6) 2022.The customer uses a normal range of 0.2 - 1.2 mg/dl.The customer stated they recalibrated the assay using the same reagent cartridge, then repeated all the patient samples which recovered higher.The customer provided 4 examples.Initial low results were reported to the physician.Sid (b)(6): 0.23 mg/dl, retested at 1.01 mg/dl.Sid (b)(6): 0.64 mg/dl, retested at 1.43 mg/dl.Sid (b)(6): 0.39 mg/dl, retested at 1.23 mg/dl.Sid (b)(6): 0.44 mg/dl, retested at 1.23 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.The customer discovered that samples were run while the quality control failed.Rerunning qc then samples has resolved the issue.This indicates the assay is performing as expected.User error may have contributed to the issue.Per the complaint text, the customer received a flag for 21 out of 25 results less than linearity but reported results out.Based on the investigation, no deficiency for lot number 60446uq08 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: 15094003
• Report Number: 3002809144-2022-00255
• Device Sequence Number: 5323510
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 07/25/2022

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: 01/31/2023
• Device Model Number: 6L45-22
• Device Catalogue Number: 06L45-22
• Device Lot Number: 60446UQ08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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, C403072
• Patient Sex: Unknown