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

Catalog Number 06L45-21

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The account generated false elevated architect total bilirubin of 47.17 umol/l on id 2141 that repeated 6.24 and <2 umol/l and beckman coulter method of approximately 6 to 7 umol/l.No specific patient details were provided.No impact to patient management was reported.

Manufacturer Narrative

A ticket search by product lot found no other complaints similar to the current complaint issue.The trend review by the product list number found no adverse or non-statistical trends related to this issue.Review of patient data in the field for the past 52 weeks suggests the total bilirubin product is performing as intended in the field.The historical performance of reagent lot 51992uq09 was evaluated using world wide data showing no unusual reagent lot performance was identified for lot 51992uq09.Labeling was reviewed and found to adequately address the issue under review.Use error may have contributed to the customer issue as a result of multiple occurrences of error code 0550 and not washing the cuvettes were found upon customer data review.In addition, the suspect results had result flags of cntl indicating a control result was out of range and that the patient results should be reviewed.No product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY TOTAL BILIRUBIN
• Type of Device: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8162023
• MDR Text Key: 130337019
• Report Number: 1628664-2018-02148
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (y/n): N
• PMA/PMN Number: K060574
• 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: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 LIST 03L77-01; ARCHITECT C16000 LIST 03L77-01,; SERIAL (B)(4); SERIAL (B)(4)