MAUDE Adverse Event Report: ABBOTT LABORATORIES TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN

Model Number 6L45-41

Device Problem High Test Results (2457)

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

Event Date 10/13/2020

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 obtained a falsely elevated architect total bilirubin result for one patient.Sample id (b)(6) generated 8.49 and repeat 0.21 mg/dl.A serum sample from the same patient was also tested, and generated 0.18 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

The evaluation of the customers issue included a review complaint data, trending, lot search and labeling.A review of tickets determined that there is normal complaint activity for lot 56892uq03.Review of trending reports did not identify any issues.Review of manufacturing documentation for the complaint lot found no issues related to the current complaint.Review of product labeling found adequate information to address the complaint issue.The information provided by the customer indicated the same patient sample and a new sample were retested with similar expected lower results.In addition, the qc results were within expected ranges indicating the product is performing as expected.Based on all available information, no systemic issue or deficiency of the architect total bilirubin assay was identified.

• Brand Name: TOTAL BILIRUBIN
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 10771438
• MDR Text Key: 214149257
• Report Number: 3016438761-2020-00279
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (y/n): N
• PMA/PMN Number: K121985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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: 08/31/2021
• Device Model Number: 6L45-41
• Device Catalogue Number: 06L45-41
• Device Lot Number: 56892UQ03
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, C804129.; ARC C8 PROC MOD, 01G06-11, C804129.; ARC C8 PROC MOD, 01G06-11, C804129