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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS ELECSYS CA 19-9 IMMUNOASSAY TEST, CARBOHYDRATE ANTIGEN (CA19-9) Back to Search Results
Catalog Number 11776193122
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
The customer questioned low results using 1 particular reagent bottle when testing patients for elecsys ca 19-9 immunoassay (ca 19-9) on an elecsys e170 modular analytics immunoassay analyzer. On (b)(6) 2018 the customer got a ca 19-9 result of < 0. 600 u/ml. The customer changed to a new reagent bottle with the same lot number and a result within the measuring range was obtained. The actual result was not provided. Afterwards, the customer switched back to the original reagent bottle. On (b)(6) 2018 the customer got a ca 19-9 result with the original reagent bottle. The result on (b)(6) 2018 was within the measuring range. The actual result was not provided. On (b)(6) 2018 six patient samples were tested for ca 19-9 and repeated. Of these 6 patient samples, the results for 1 patient sample were discrepant. The initial result was < 0. 6 u/ml. The repeat result was 25. 2 u/ml. No alarms were generated with the low result. The incorrect result was not reported outside of the laboratory. There was no allegation that an adverse event occurred. The e 170 analyzer serial number was (b)(4). The customer stated there were 30 tests remaining the reagent bottle in question. They started using it at the end of (b)(6) 2018.
 
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Brand NameELECSYS CA 19-9 IMMUNOASSAY
Type of DeviceTEST, CARBOHYDRATE ANTIGEN (CA19-9)
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 Key7697661
MDR Text Key114287415
Report Number1823260-2018-02374
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
Report Date 08/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number11776193122
Device Lot Number312851
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 Received07/05/2018
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

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