CLINICAL CHEMISTRY TOTAL BILIRUBIN 06L45-41

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-26 for CLINICAL CHEMISTRY TOTAL BILIRUBIN 06L45-41 manufactured by Abbott Manufacturing Inc.

Event Text Entries

[129328921] Complete information for patient information, patient identifier, multiple = (b)(6). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There was no further patient information provided by the customer.
Patient Sequence No: 1, Text Type: N, H10


[129328922] The customer reported that they are observing falsely elevated total bilirubin on their architect compared to what their sister site is getting on both patient results and controls. The example results provided were for 2 adult patients: (b)(6) on (b)(6) 2018 =1. 9mg/dl (range = 0-1. 2mg/dl) / sample sent to arup = 1. 1 / previously on (b)(6) 2017 by roche = 1. 3; (b)(6) on (b)(6) 2018 = 2. 3mg/dl / sent to arup = 1. 4 / previously in 2017 = 0. 8 (unknown method). There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1628664-2018-02032
MDR Report Key8101461
Report SourceHEALTH PROFESSIONAL
Date Received2018-11-26
Date of Report2019-01-16
Date of Event2018-09-04
Date Mfgr Received2019-01-11
Device Manufacturer Date2018-04-06
Date Added to Maude2018-11-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNOEMI ROMERO-KONDOS, RN BSN
Manufacturer Street100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224667-512
Manufacturer G1ABBOTT MANUFACTURING INC
Manufacturer Street1921 HURD DRIVE
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal Code75038
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLINICAL CHEMISTRY TOTAL BILIRUBIN
Generic NameTOTAL BILIRUBIN
Product CodeCIG
Date Received2018-11-26
Catalog Number06L45-41
Lot Number52656UQ02
Device Expiration Date2019-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MANUFACTURING INC
Manufacturer Address1921 HURD DRIVE IRVING TX 75038 US 75038


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-26

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