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

Model Number	6L45-42
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a falsely depressed architect total bilirubin result.On (b)(6) 2021 sample id (b)(6) generated 16.4 and repeat 117 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.Patient information: no further information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer obtained a falsely depressed architect total bilirubin result.On (b)(6) 2021 sample id (b)(6) generated 16.4 and repeat 117 umol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
It was discovered on april 21, 2021 that the initial emdr for this issue was submitted under the correct suspect medical device but incorrect manufacturer name, city and state.Mdr number 3002809144-2021-00282 has been submitted for the correct manufacturing site and all further information will be documented under that mdr number.H3 other text : refer to new mdr 3002809144-2021-00282 for device evaluation.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.H3 other text: refer to mdr 3002809144-2021-00282.

• Brand Name: TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• MDR Report Key: 11694010
• Report Number: 3016438761-2021-00151
• Device Sequence Number: 3128119
• Product Code: CIG
• UDI-Device Identifier: 00380740174972
• UDI-Public: 00380740174972
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/24/2021

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 Model Number: 6L45-42
• Device Catalogue Number: 06L45-42
• Device Lot Number: 58020UQ08
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 06/24/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 04/30/2021; 06/24/2021
• 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, C1600672; ARC C16K PRC MOD, 03L77-01, C1600672; ARC C16K PRC MOD, 03L77-01, C1600672