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

Model Number 6L45-21

Device Problem High Test Results (2457)

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

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid: (b)(6).All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated architect total bilirubin results on a (b)(6)-year-old female patient.The results generated on (b)(6) 2020 were: sid: (b)(6); initial result = 150.5 umol/l, retested on another instrument = 14 umol/l (reference range: <30umol/l).No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 55933uq09.Return testing was not completed as returns were not available.Review of tracking and trending reports did not identify any related trends for the issue for the product.File sample analysis was not performed as the issue appears to be specific to the patient sample and/or the reagent cartridge.After the reagent cartridge was replaced, the patient sample gave a normal result and quality control (qc) results were within expected ranges.Review of other patient samples from the day of the issue found this issue did not recur.In addition, historical performance was reviewed using worldwide data for the total bilirubin assay which shows complaint lot 55933uq09 is performing as expected in the field.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no product deficiency was identified for the total bilirubin reagent (ln 6l45-21) lot 55933uq09.

• Brand Name: TOTAL BILIRUBIN
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 10899176
• MDR Text Key: 218977662
• Report Number: 3016438761-2020-00313
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (y/n): N
• PMA/PMN Number: K121985
• 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: 12/16/2020

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: 02/28/2021
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 55933UQ09
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1600969.; ARC C16K PRC MOD, 03L77-01, C1600969.
• Patient Age: 60 YR