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

Model Number	6L45-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a physician is questioning elevated total bilirubin results generated on the architect c8000 analyzer on two patients.Results provided: (uom mg/dl) newborn female.(b)(6) 2022 sid (b)(6) = 7.4, ref range [0.0-10.0], (b)(6) 2022 sid (b)(6) = 17.8, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 16.8, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) results are 13.5, ref range [0.0-13.2], (b)(6) 2022 (b)(6) results are 11.4, ref range [0.0-7.3].Newborn male (b)(6) 2022 sid (b)(6) = 8.7, ref range [0.0-10.0], (b)(6) 2022 sid (b)(6) = 19.3, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 19.5, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 14.1, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 12.5, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 12.0, ref range [0.0-17.4], (b)(6) 2022 sid (b)(6) = 18.8, ref range [0.0-7.3].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.Section a1 patient identifier sids: newborn female, (b)(6) 2022 sid (b)(6), (b)(6) 2022 sid (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6).Newborn male: (b)(6) 2022 sid (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6), (b)(6) 2022 (b)(6).
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 60977uq01.Trending review determined no trends for falsely depressed results for the product.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The historical performance of reagent lot 60977uq01 was evaluated using world-wide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 60977uq01 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 60977uq01.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no deficiency of the architect total bilirubin reagent lot number 60977uq01 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: 15939461
• Report Number: 3002809144-2022-00425
• Device Sequence Number: 17743363
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• 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): 01/22/2023

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: 06/30/2023
• Device Model Number: 6L45-22
• Device Catalogue Number: 06L45-22
• Device Lot Number: 60977UQ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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).
• Patient Sex: Unknown