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Catalog Number 02K42-28
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Further investigation of the issue included a review of the complaint text, a search for similar complaints, review of instrument logs, in-house testing and a review of labeling. Review of complaint activity determined that there is normal complaint activity for likely cause lot 79350un17. Tracking and trending report review for the architect stat ck-mb assay determined that there are no related adverse or non-statistical trends. In addition, a device history record review was performed on lot 79350un17, which did not identify any issues. The customer's instrument logs were reviewed for the samples tested in january 2018. This review did not identify conclusive information to indicate an instrument or sample integrity issue occurred. An internal ck-mb panel was tested with retained kits of the likely cause reagent lot. Acceptance criteria were met, which indicates acceptable product performance. Additionally, labeling was reviewed and sufficiently addresses the customer's issue. Based on the available information, no systemic issue or deficiency of the architect stat ck-mb assay was identified.
Manufacturer Narrative
Section reason why the device was not evaluated was changed.
Manufacturer Narrative
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 stat ck-mb results for two patients. The first patient (sample id (b)(6)) generated a ck-mb result of 32. 0 ng/ml. A new sample ((b)(6)) drawn 3 hours later generated a ck-mb of 2. 0 ng/ml. The second patient (sample id (b)(6)) generated a ck-mb result of 17. 9 ng/ml and retest (sid (b)(6)) 2. 3 ng/ml. A second sample drawn 3 hours later (sid (b)(6)) generated a ck-mb result of 2. 2 ng/ml and retest (sid (b)(6)) 2. 3 ng/ml. No specific patient information was provided and no adverse impact to patient management was reported.
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Type of DeviceCK-MB
Manufacturer (Section D)
100 abbott park road
abbott park IL 60064 3500
MDR Report Key7203536
MDR Text Key263235807
Report Number1415939-2018-00004
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
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 02/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue Number02K42-28
Device Lot Number79350UN17
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/18/2018 Patient Sequence Number: 1
ARCHITECT I1000SR; ARCHITECT I1000SR; ARCHITECT I1000SR; LIST 01L86-97, SERIAL (B)(4).; LIST 01L86-97, SERIAL (B)(4).; LIST 01L86-97, SERIAL B)(4).