MAUDE Adverse Event Report: ABBOTT GMBH TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

Model Number 6L45-22

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: pt#1 (b)(6)- year old male; pt#2 (b)(6) year old female; pt#3 (b)(6) year old male 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.

Event Description

The customer reported false negative architect total bilirubin assay results for several patients.The customer alleges this issue to be associated with the onset of the use of a new lot of the total bilirubin calibrator (ln 01e66-04, lot 05647d01).The customer provided: pt#1 ((b)(6)- year old male): 20.2 umol/l, 12.922 umol/l; pt#2 ((b)(6)- year old female): 3.8 umol/l, 2.82 umol/l; pt# 3 ((b)(6)- year old male) 6.8 umol/l, 5.155 umol/l (reference range: 3.4 to 20.5 umol/l).There was no impact to patient management reported.

Manufacturer Narrative

The trend review by the product list number found no adverse trends related to this issue.A review of labeling address the customer issues.The labeling for the bilirubin calibrator and architect system was reviewed.The bilirubin calibrator package insert and architect operations manual provide adequate instructions for use of the assay as well as troubleshooting information intended to assist the operator with investigation of depressed results.There are lot to lot variation or differences between each bilirubin calibrator lot and each total bilirubin reagent lot produced.Each product must meet specifications prior to release for sale or distribution.Each product lot met expected specifications.No product deficiency was identified.

• Brand Name: TOTAL BILIRUBIN
• Type of Device: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10548073
• MDR Text Key: 207583335
• Report Number: 3002809144-2020-00934
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: 00380740174965
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2021
• Device Model Number: 6L45-22
• Device Catalogue Number: 06L45-22
• Device Lot Number: 56664UQ01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, (B)(6).; ARCHITECT C16000 ANALYZER; LN 03L77-01, SN (B)(6)