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

Catalog Number 06L45-21

Device Problem Low Test Results (2458)

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

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, and labeling review.The product was not returned.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.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

Event Description

The customer observed falsely depressed results while using clinical chemistry total bilirubin reagents.The following data was provided for the same newborn patient.The customer uses normal range 0.3 to 1.5 mg/dl and critical value greater than 14.9 mg/dl.Sid: (b)(6).Specimen drawn on (b)(6) 2018 at 30 hours of life was lower, 0.4 mg/dl.Previous and subsequent specimen results for the same patient were higher.Specimen drawn on (b)(6) 2018, at 3 hours of life, 3.5 mg/dl.Specimen drawn on (b)(6) 2018 at 29 hours of life) initial 29.0 mg/dl.Specimens drawn on (b)(6) 2018 12.0, 13.0 mg/dl.Specimen drawn on (b)(6) 2018 10.7 mg/dl.Advance br2 method was higher for the specimen drawn on (b)(6) 2018 at 30 hours (8.6 mg/dl).No adverse 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: 8016271
• MDR Text Key: 126663869
• Report Number: 1628664-2018-01978
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2018

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: 10/31/2019
• Device Catalogue Number: 06L45-21
• Device Lot Number: 53066UQ05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA