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

Model Number	6L45-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 10899176
• Report Number: 3016438761-2020-00313
• Device Sequence Number: 11440357
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C16K PRC MOD, 03L77-01, C1600969.; ARC C16K PRC MOD, 03L77-01, C1600969.
• Patient Age: 60 YR