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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT MYOGLOBIN REAGENT KIT MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

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ABBOTT LABORATORIES ARCHITECT STAT MYOGLOBIN REAGENT KIT MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL Back to Search Results
Model Number 2K43-20
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
Event Type  malfunction  
Manufacturer Narrative
Patient identifier
=
sid
=
(b)(6). (b)(4). Was this device serviced 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 observed falsely elevated architect stat myoglobin results on one patient. The results provided were: sid (b)(6) initial
=
1003. 7 ng/ml / repeated due to questioned by physician
=
51 ng/ml there was no reported impact to patient management.
 
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Brand NameARCHITECT STAT MYOGLOBIN REAGENT KIT
Type of DeviceMYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
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
christian lee
100 abbott park road
dept. 09b9, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key11801795
MDR Text Key252345829
Report Number1415939-2021-00022
Device Sequence Number1
Product Code DDR
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Model Number2K43-20
Device Catalogue Number02K43-20
Device Lot Number57557UN20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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