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

Model Number 6L45-22

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  malfunction  

Event 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.

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).

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
• Type of Device: 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
• MDR Text Key: 308260583
• Report Number: 3002809144-2022-00425
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, (B)(6).; ARC C8 PROC MOD, 01G06-11, (B)(6).