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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE REAGENT KIT
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ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE REAGENT KIT Back to Search Results
Catalog Number 01L75-25
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2023
Event Type  malfunction  
Manufacturer Narrative
A1 patient identifier: complete sample id is (b)(6).All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported falsely elevated architect cyclosporine, which reportedly occurred on approximately 3 patients.The customer stated that the results were questioned, and samples were processed again with a new pretreatment set up, and result was lower.The customer provided the follow data for 1 patient: customer reference range is: 100.0 ng/dl to 400 ng/ml sample id (b)(6): on 12/18 initial result was 167.5, and repeat result was <30 and <30.There was no reported impact to patient management.
 
Event Description
The customer reported falsely elevated architect cyclosporine, which reportedly occurred on approximately 3 patients.The customer stated that the results were questioned, and samples were processed again with a new pretreatment set up, and result was lower.The customer provided the follow data for 1 patient: customer reference range is: 100.0 ng/dl to 400 ng/ml sample id (b)(6): on 12/18 initial result was 167.5, and repeat result was <30 and <30.There was no reported impact to patient management.Update: additional information received: the customer reported that the issue was due to a human error with the preparation.
 
Manufacturer Narrative
Additional information can be seen in section b5.
 
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Brand Name
ARCHITECT CYCLOSPORINE REAGENT KIT
Type of Device
CYCLOSPORINE
Manufacturer (Section D)
ABBOTT LABORATORIES
100 abbott park road
abbott park IL 60064
Manufacturer (Section G)
ABBOTT LABORATORIES
100 abbott park road
abbott park IL 60064
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18470051
MDR Text Key332730944
Report Number1415939-2024-00002
Device Sequence Number1
Product Code MKW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number01L75-25
Device Lot Number55721FP00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC I1000SR MOD, 01L86-01, I1SR60154; ARC I1000SR MOD, 01L86-01, I1SR60154; ARC I1000SR MOD, 01L86-01, I1SR60154
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