MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

Catalog Number 06L45-41

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, instrument log review, and labeling review.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.Log review did not identify any issues that contributed to the customer issue.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.This issue was previously reported under mdr number 1415939-2018-00045 under a different suspect device manufacturer.

Event Description

The customer observed multiple falsely elevated total bilirubin results while using the clinical chemistry total bilirubin reagents.The following data was provided.Sid (b)(6) initial 1.636 mg/dl, repeat 0.509 mg/dl, sid (b)(6) initial 1.807 mg/dl, repeat 0.717 mg/dl, sid (b)(6) initial 1.646 mg/dl, repeat 0.493 mg/dl, sid (b)(6) initial 1.795 mg/dl, repeat 0.674 mg/dl, sid (b)(6) initial 1.582 mg/dl, repeat 0.443 mg/dl, sid (b)(6) initial 1.581 mg/dl, repeat 0.431 mg/dl, sid (b)(6) initial 2.088 mg/dl, repeat 1.045 mg/dl, sid (b)(6) initial 1.711 mg/dl, repeat 0.578 mg/dl, sid (b)(6) initial 1.654 mg/dl, repeat 0.512 mg/dl, sid (b)(6) initial 1.778 mg/dl, repeat 0.66 mg/dl, sid (b)(6) initial 1.835 mg/dl, repeat 0.781 mg/dl, sid (b)(6) initial 1.648 mg/dl, repeat 0.528 mg/dl, sid (b)(6) initial 1.623 mg/dl, repeat 0.453 mg/dl, sid (b)(6) initial 1.605 mg/dl, repeat 0.472 mg/dl, sid (b)(6) initial 1.474 mg/dl, repeat 0.34 mg/dl, sid (b)(6) initial 1.699 mg/dl, repeat 0.592 mg/dl, sid (b)(6) initial 1.548 mg/dl, repeat 0.427 mg/dl, sid (b)(6) initial 1.734 mg/dl, repeat 0.608 mg/dl, sid (b)(6) initial 1.425 mg/dl, repeat 0.278 mg/dl, sid (b)(6) initial 1.756 mg/dl, repeat 0.625 mg/dl, sid (b)(6) initial 1.648 mg/dl, repeat 0.505 mg/dl, sid (b)(6) initial 1.373 mg/dl, repeat 0.203 mg/dl, sid (b)(6) initial 1.412 mg/dl, repeat 0.262 mg/dl, sid (b)(6) initial 1.335 mg/dl, repeat 0.193 mg/dl, sid (b)(6) initial 1.915 mg/dl, repeat 0.828 mg/dl, sid (b)(6) initial 1.383 mg/dl, repeat 0.219 mg/dl, sid (b)(6) initial 1.909 mg/dl, repeat 0.802 mg/dl, sid (b)(6) initial 2.137 mg/dl, repeat 1.087 mg/dl, sid (b)(6) initial 1.603 mg/dl, repeat 0.469 mg/dl, sid (b)(6) initial 1.695 mg/dl, repeat 0.564 mg/dl, sid (b)(6) initial 1.508 mg/dl, repeat 0.337 mg/dl, sid (b)(6) initial 1.896 mg/dl, repeat 0.804 mg/dl, sid (b)(6) initial 1.638 mg/dl, repeat 0.514 mg/dl, sid (b)(6) initial 1.494 mg/dl, repeat 0.321 mg/dl, sid (b)(6) initial 2.027 mg/dl, repeat 0.972 mg/dl, sid (b)(6) initial 1.705 mg/dl, repeat 0.594 mg/dl, sid (b)(6) initial 1.658 mg/dl, repeat 0.53 mg/dl, sid (b)(6) initial 1.674 mg/dl, repeat 0.564 mg/dl, sid (b)(6) initial 1.738 mg/dl, repeat 0.608 mg/dl, sid (b)(6) initial 1.615 mg/dl, repeat 0.481 mg/dl, sid (b)(6) initial 1.695 mg/dl, repeat 0.557 mg/dl, sid (b)(6) initial 1.668 mg/dl, repeat 0.54 mg/dl, sid (b)(6) initial 1.689 mg/dl, repeat 0.568 mg/dl, sid (b)(6) initial 1.394 mg/dl, repeat 0.233 mg/dl, sid (b)(6) initial 2.092 mg/dl, repeat 1 mg/dl, sid (b)(6) initial 1.953 mg/dl, repeat 0.87 mg/dl, sid (b)(6) initial 1.471 mg/dl, repeat 0.288 mg/dl, sid (b)(6) initial 1.778 mg/dl, repeat 0.679 mg/dl, sid (b)(6) initial 1.742 mg/dl, repeat 0.627 mg/dl, sid (b)(6) initial 1.782 mg/dl, repeat 0.658 mg/dl, sid (b)(6) initial 2.909 mg/dl, repeat 1.916 mg/dl, sid (b)(6) initial 1.44 mg/dl, repeat 0.288 mg/dl, sid (b)(6) initial 1.752 mg/dl, repeat 0.623 mg/dl, sid (b)(6) initial 1.709 mg/dl, repeat 0.571 mg/dl, sid (b)(6) initial 1.957 mg/dl, repeat 0.867 mg/dl, sid (b)(6) initial 3.045 mg/dl, repeat 2.082 mg/dl, sid (b)(6) initial 1.959 mg/dl, repeat 0.854 mg/dl, sid (b)(6) initial 1.636 mg/dl, repeat 0.493 mg/dl, sid (b)(6) initial 1.825 mg/dl, repeat 0.733 mg/dl, sid (b)(6) initial 2.491 mg/dl, repeat 1.467 mg/dl, sid (b)(6) initial 1.45 mg/dl, repeat 0.287 mg/dl, sid (b)(6) initial 2.163 mg/dl, repeat 1.122 mg/dl no impact to patient management was reported.

• Brand Name: CLINICAL CHEMISTRY TOTAL BILIRUBIN
• Type of Device: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 7400545
• MDR Text Key: 105245715
• Report Number: 1628664-2018-00136
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 06L45-41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1