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

Catalog Number 06L45-21

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information patient 1 ((b)(6)) and patient 3 ((b)(6)) were (b)(6).Patient 2 ((b)(6)) age was not provided.An evaluation is in process.

Event Description

The customer observed multiple falsely elevated total bilirubin results while using clinical chemistry total bilirubin reagents.The following data was provided.Patient 1 ((b)(6)) initial 11.94 mg/dl, other methods were lower including siemens (7.55 mg/dl) and cobas/roche (7.2 mg/dl).Patient 2 ((b)(6)) initial 23.85 mg/dl, other methods were lower including siemens (10.74 mg/dl) and cobas/roche (10.3 mg/dl).Patient 3 ((b)(6)) initial 23.41 mg/dl, other methods were lower including siemens (12.01 mg/dl) and cobas/roche (11.8 mg/dl).No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history 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.A proficiency data review (college of american pathologists, cap) was completed.Review of participant summaries showed abbott method was well aligned in the recovery of the cap educational sample which has a reference method value (gold standard).Siemens advia method recovered higher than other siemens methods (dimension and dimension vista).Siemens methods (dimension and dimension vista) were comparable to abbott and roche methods.No unusual abbott method reagent performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• 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: 7343381
• MDR Text Key: 103148611
• Report Number: 1628664-2018-00115
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K060574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 06L45-21
• Device Lot Number: 51992UQ09
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• 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