MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING ATM) TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

Model Number	6L45-41
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: multiple = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.
Event or Problem Description
The customer reported falsely depressed total bilirubin results on approximately 30 patients generated on the architect analyzer.The customer stated the level i control for total bilirubin was out of range low in the afternoon.The morning qc had been acceptable.The customer repeated all patient samples from the morning.The results provide were for 12 samples: on (b)(6) original = 10.8 /amended =14 (current acceptance range <20umol/l); sid (b)(6) = 3.1 /amended= 6; sid (b)(6) =2.4 / amended = 5; sid (b)(6) = 4.4 /amended= 7; sid (b)(6) = 9.9 / amended =14; sid (b)(6) = 5.3 / amended= 8; sid (b)(6) = 3 / rerun: 5; sid (b)(6) = 13 / rerun = 16; sid (b)(6) = 7 / rerun = 10; sid (b)(6) = 12 / rerun = 15; sid (b)(6) = 7 / rerun = 9; sid (b)(6) = 9 / rerun = 12umol/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of tickets determined that there are no other complaints for lot 55179uq05, and no trends were identified for the complaint issue.Returns were available but not required for the investigation.Labeling describes the proper reagent handling required to successfully use the assay on the architect system.Indications of reagent deterioration or instability should be suspected if there are precipitates, visible signs of leakage or contamination, turbidity, or if calibration or controls do not meet the appropriate package insert.In addition, the architect system operations manual provides guidance for assay results in regard to symptoms, other test results, clinical impressions and other diagnostic procedures that must be considered for patient care management.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Based on the investigation no product deficiency was identified for the total bilirubin reagent, lot 55179uq05.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING ATM); 1921 hurd drive; irving TX 75038
• MDR Report Key: 9751255
• Report Number: 1628664-2020-00076
• Device Sequence Number: 740925
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060574
• 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): 03/18/2020

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: 10/31/2020
• Device Model Number: 6L45-41
• Device Catalogue Number: 06L45-41
• Device Lot Number: 55179UQ05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/18/2020
• 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: ARCHITECT C4000 ANALYZER, LN 02P24-40,; ARCHITECT C4000 ANALYZER, LN 02P24-40,; SERIAL # (B)(6); SERIAL # (B)(6)