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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG TEST SYSTEM; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
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ROCHE DIAGNOSTICS ELECSYS HCG TEST SYSTEM; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN Back to Search Results
Catalog Number 03300811190
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys hcg stat (hcg stat) on a cobas e 411 immunoassay analyzer.The initial result was 0.8 miu/ml.This result was reported outside of the laboratory.The repeat result after calibration was < 0.5 miu/ml.The e411 analyzer serial number is (b)(4).
 
Manufacturer Narrative
The results observed by the customer were within expectations with re-calibration between results.Re-calibration could cause the slight numerical difference in results; the result difference is not clinically significant.The investigation did not identify a product problem.The cause of the event could not be determined.
 
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Brand Name
ELECSYS HCG TEST SYSTEM
Type of Device
SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10725487
MDR Text Key212739006
Report Number1823260-2020-02625
Device Sequence Number1
Product Code DHA
Combination Product (y/n)N
PMA/PMN Number
K002148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03300811190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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