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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT CYCLOSPORINE REAGENT KIT
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ABBOTT IRELAND ARCHITECT CYCLOSPORINE REAGENT KIT Back to Search Results
Catalog Number 03R30-25
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
Event Description
The customer observed falsely decreased architect cyclosporine result which questioned by physician on one patient.The results provided were: initial=63 ng/ml /repeated=69 ng/ml /redrawn and repeated on same patient=170 ng/ml and 180 ng/ml /initial specimen repeated=69 ng/ml 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.
 
Manufacturer Narrative
This follow-up submission being send to cross reference mdr 1415939-2022-00047-00 for likely cause changed on 19jun2022; architect cyclosporine reagent kit, list number 03r30-25 to architect cyclosporine whole blood precipitation reagent kit, list 01l75-55.After further evaluation it was determined that the cause of the issue was the architect cyclosporine whole blood precipitation reagent kit, list 01l75-55.) (abbottpark, il as manufacturing site) and submitted under manufacturer report number 1415939-2022-00047-00.
 
Event Description
The customer observed falsely decreased architect cyclosporine result which questioned by physician on one patient.The results provided were: initial=63 ng/ml /repeated=69 ng/ml /redrawn and repeated on same patient=170 ng/ml and 180 ng/ml /initial specimen repeated=69 ng/ml there was no reported impact to patient management.
 
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Brand Name
ARCHITECT CYCLOSPORINE REAGENT KIT
Type of Device
CYCLOSPORINE
Manufacturer (Section D)
ABBOTT IRELAND
finisklin business park
sligo F91VY 44
EI  F91VY44
Manufacturer (Section G)
ABBOTT IRELAND
finisklin business park
sligo F91VY 44
EI   F91VY44
Manufacturer Contact
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key14735289
MDR Text Key297672440
Report Number3008344661-2022-00066
Device Sequence Number1
Product Code MKW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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 06/27/2022
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
Device Operator Health Professional
Device Catalogue Number03R30-25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/09/2022
Initial Date FDA Received06/17/2022
Supplement Dates Manufacturer Received06/19/2022
Supplement Dates FDA Received06/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).
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