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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN
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ABBOTT GMBH TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN Back to Search Results
Model Number 6L45-22
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Event Description
The customer observed falsely elevated total bilirubin results on architect c8000 processing module for one patient.The results provided were: initial=174.5 umol/l and 177.3 umol/l /repeated=normal (no actual results provided) laboratory reference range for total bilirubin=3.4 to 20.5 umol/l there was no reported impact to patient management.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed falsely elevated total bilirubin results on architect c8000 processing module for one patient.The results provided were: initial=174.5 umol/l and 177.3 umol/l /repeated=normal (no actual results provided) laboratory reference range for total bilirubin=3.4 to 20.5 umol/l there was no reported impact to patient management.
 
Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review for architect total bilirubin reagent ln 6l45, lot number 62175uq05.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.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.From the information provided by customer technical support, the false elevated results the customer observed, is due to the large quantity of bubbles being present in the reagent.Once these were removed, the sample was re-tested, and qc was run again.The sample result returned to normal, and qc was in range.The issue was resolved by troubleshooting.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect total bilirubin reagent, lot number 62175uq05.
 
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Brand Name
TOTAL BILIRUBIN
Type of Device
DIAZO COLORIMETRY, BILIRUBIN
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM   65205
Manufacturer Contact
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key16619282
MDR Text Key312383831
Report Number3002809144-2023-00167
Device Sequence Number1
Product Code CIG
UDI-Device Identifier00380740174965
UDI-Public00380740174965
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K121985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2023
Device Model Number6L45-22
Device Catalogue Number06L45-22
Device Lot Number62175UQ05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ARC C16K PRC MOD, 03L77-01, (B)(6) ; ARC C16K PRC MOD, 03L77-01, (B)(6)
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