MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC TOTAL BILIRUBIN; TOTAL BILIRUBIN REAGENT

Catalog Number	06L45-41
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.This event is also being submitted in manufacturer report number 1628664-2019-00646, for a second suspect medical device, list 03l77-97.
Event or Problem Description
The customer reported multiple false decreased total bilirubin results when processing on the architect c16000.Initial results ranged from 1.9 to 38.4 and retest results ranged from 8 to 46.No impact to patient management was reported.
Additional Manufacturer Narrative
On 07oct2019, list 06l45-41was no longer determined to be a suspect medical device for this event.The final investigation has been submitted in manufacturer report number 1628664-2019-00646, for the correct suspect medical device.No further information will be submitted under this manufacturer report number.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: TOTAL BILIRUBIN REAGENT
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9143743
• Report Number: 1628664-2019-00645
• Device Sequence Number: 11405005
• Product Code: CIG
• UDI-Device Identifier: 00380740011383
• UDI-Public: 00380740011383
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 10/21/2019

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 Catalogue Number: 06L45-41
• Device Lot Number: 54329UQ12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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 C16000, LIST 03L77-97; SERIAL (B)(4)