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	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated direct bilirubin results when compare to total bilirubin on architect c16000 processing module for one patient.The results provided were: total bilirubin on architect=1.7 mg/dl/ repeated on same analyzer=1.6 mg/dl/ repeated on alinity=2.07 mg/dl/ repeated on siemens exl=2.6 mg/dl laboratory reference range for architect total bilirubin=0.2 mg/dl to 1.2 mg/dl laboratory reference range for exl total bilirubin=0.2 mg/dl to 1.0 mg/dl there was no reported impact to patient management.
Additional Manufacturer Narrative
Additional information provided: describe event or problem b5: event date and sid provided.The customer observed falsely elevated direct bilirubin results when compare to total bilirubin on architect c16000 processing module for one patient.The results provided were: on (b)(6) 2020 (b)(6) total bilirubin on architect=1.7 mg/dl/ repeated on same analyzer=1.6 mg/dl/ repeated on alinity=2.07 mg/dl/ repeated on siemens exl=2.6 mg/dl laboratory reference range for architect total bilirubin=0.2 mg/dl to 1.2 mg/dl laboratory reference range for exl total bilirubin=0.2 mg/dl to 1.0 mg/dl there was no reported impact to patient management.
Additional Manufacturer Narrative
A review of complaints for lot 56326uq11 identified only one other complaint for total bilirubin results.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Per product labeling, the presence of fibrin, bubbles or particulate matter in the sample may cause an erroneous result.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is sufficiently addressed in the labeling.Based on the investigation no product deficiency was identified for the architect total bilirubin reagent, lot 56326uq11.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 10786914
• Report Number: 3016438761-2020-00283
• Device Sequence Number: 2904149
• Product Code: CIG
• UDI-Device Identifier: 00380740011369
• UDI-Public: 00380740011369
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/26/2021

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: 04/30/2021
• Device Model Number: 6L45-21
• Device Catalogue Number: 06L45-21
• Device Lot Number: 56326UQ11
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 11/02/2020; 01/26/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/26/2020; 01/26/2021
• 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, C1601273; ARC C16K PRC MOD, 03L77-01, C1601273; ARC C16K PRC MOD, 03L77-01, C1601273