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 Date 03/27/2016

Event Type  malfunction  

Manufacturer Narrative

Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a batch record review, and a labeling review.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Batch record review did not identify any issues that may have caused the customer issue.Based on all available information and abbott diagnostics complaint investigation, no product deficiency was identified.(b)(6).

Event Description

The customer observed elevated bilirubin results while using the clinical chemistry total bilirubin reagents.The following data, generated on (b)(6) 2016, was provided for the same patient (umol/l).The patient was a (b)(6) baby.Sid (b)(6) (replicate id (b)(6)) initial 374.9.Sid (b)(6) (replicate id (b)(6)) retest (1:30 hours later) 180.0.Sid (b)(6) (replicate id (b)(6) ) retest 179.8.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: 6530882
• MDR Text Key: 74152306
• Report Number: 1628664-2017-00161
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 06L45-21
• Device Lot Number: 47839UQ06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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
• Treatment: ARCHITECT C4000 ANALYZER; LIST NUMBER 02P24-40; SERIAL NUMBER (B)(4)
• Patient Age: 2 DA