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

Model Number 6L45-21

Device Problem High Test Results (2457)

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

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated total bilirubin results on architect c16000 processing module for one pediatric patient.The results provided were: on (b)(6) 2020, sid: (b)(6); initial total bilirubin=22.29 mg/dl/ repeated on alinity=21 mg/dl and 20 mg/dl/ repeated on roche instrument=15.5 mg/dl there was no reported impact to patient management.

Manufacturer Narrative

A ticket search was performed for the architect total bilirubin, reagent lot number 56776uq02.An investigation was performed for the customer issue and included a review of the complaint text, a search for tracking and trending, a review of historical performance and product labeling.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the total bilirubin assay, lot number 56776uq02 was identified.

• Brand Name: TOTAL BILIRUBIN
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 10678182
• MDR Text Key: 211481815
• Report Number: 3016438761-2020-00247
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (y/n): N
• PMA/PMN Number: K121985
• 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: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 56776UQ02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1601165.; ARC C16K PRC MOD, 03L77-01, C1601165.