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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT CK-MB REAGENT KIT; FLUOROMETRIC METHOD, CPK OR ISOENZYMES
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ABBOTT LABORATORIES ARCHITECT STAT CK-MB REAGENT KIT; FLUOROMETRIC METHOD, CPK OR ISOENZYMES Back to Search Results
Catalog Number 02K42-28
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
Health effect impact code: (b)(4).Was this device service by a third party? no.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported a falsely elevated architect stat ck-mb result on a patient.Results provided: (b)(6) 2021, sid 0406143013 = 23.0 / 1.7 ng/ml.Normal range up to 6.0 ng/ml no impact to patient management was reported.
 
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.
 
Manufacturer Narrative
The complaint investigation for false elevated architect stat ck-mb result included a search for similar complaints, and review of complaint text, trending data, labeling, and device history records.In-house accuracy testing of reagent lot 35630un20 was completed.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review on lot 35630un20 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.In house testing of panels which mimic patient samples was completed using retained samples of the complaint lot.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect stat ck-mb reagent lot 35630un20 assay was identified.
 
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Brand Name
ARCHITECT STAT CK-MB REAGENT KIT
Type of Device
FLUOROMETRIC METHOD, CPK OR ISOENZYMES
Manufacturer (Section D)
ABBOTT LABORATORIES
100 abbott park road
abbott park IL 60064
MDR Report Key11732733
MDR Text Key267658641
Report Number1415939-2021-00019
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
PMA/PMN Number
K041596
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Catalogue Number02K42-28
Device Lot Number35630UN20
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARC I1000SR INTGR, 01L86-40, I1SR03832; ARC I1000SR INTGR, 01L86-40, I1SR03832; ARC I1000SR INTGR, 01L86-40, I1SR03832
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