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

Catalog Number 06L45-21

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/26/2018

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 customer observed discrepant bilirubin results while using clinical chemistry total bilirubin reagents.The following data was provided.The customer uses normal range 0.2 to 1.2 mg/dl.(b)(6), initial (undiluted) 0.91 mg/dl, repeat (autodiluted) 1.77, 2.95 mg/dl.No impact to patient management was reported.

Event Description

Update september 5, 2018: the customer stated they suspect the neat results were correct, and the undiluted (neat) results were reported out of the lab.

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, instrument log review, and labeling review.Returns were not available.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Log review did not identify any issues that contributed to 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.Describe event or problem was updated.

• 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: 7724551
• MDR Text Key: 115377697
• Report Number: 1628664-2018-00617
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 06L45-21
• Device Lot Number: 52778UQ03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LN 02P24-40 SN C402059; LN 02P24-40 SN C402059