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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CA 19-9 ELECSYS E2G CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM

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ROCHE DIAGNOSTICS CA 19-9 ELECSYS E2G CARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM Back to Search Results
Model Number CA 19-9 ELECSYS E2G
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). Medwatch field expiration date: april 2022. Medwatch field udi number: (b)(4).
 
Event Description
The initial reporter stated they received questionable results for one patient sample tested with the elecsys ca 19-9 immunoassay on two cobas 8000 e 801 module analyzers. The results did not agree with the clinical condition of the patient. The patient sample was tested twice on the customer's e 801 analyzer, resulting in ca 19-9 values of < 2. 0 u/ml and < 2. 0 u/ml (reference range
=
< 37 u/ml). These results were reported outside of the laboratory to the physician. The sample was repeated on an abbott architect analyzer, resulting in a ca 19-9 value of 775 u/ml (reference range
=
< 37 u/ml). The sample was also provided for investigation, where it was tested on a second e 801 analyzer, resulting in a ca 19-9 value of 2. 600 u/ml. The serial number of the customer's e 801 analyzer was requested, but not provided. Ca 19-9 reagent lot 504743, with an expiration date of april 2022 was used on this analyzer. The serial number of the e 801 analyzer used for investigation is (b)(4). Ca 19-9 reagent lot 504743, with an expiration date of april 2022 was used on this analyzer.
 
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Brand NameCA 19-9 ELECSYS E2G
Type of DeviceCARBOHYDRATE ANTIGEN (CA19-9) TEST SYSTEM
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM 68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key11768369
MDR Text Key250243244
Report Number1823260-2021-01328
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050231
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCA 19-9 ELECSYS E2G
Device Catalogue Number07027028190
Device Lot Number504743
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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