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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS ELECSYS CA 19-9 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 05/27/2016
Event Type  malfunction  
Event Description
The customer stated that they received erroneous results for one patient sample tested for carbohydrate antigen 19-9 (b)(4) on an e170 analyzer. The results from the e170 analyzer were reported outside of the laboratory and were questioned by a doctor. The sample initially resulted as 262 u/ml on the e170 analyzer. The sample was tested on an architect analyzer, resulting as 3354 u/ml. The sample was repeated on (b)(6) 2016, resulting as 276 u/ml on the e170 analyzer. The sample was also repeated on the architect analyzer on (b)(6) 2016, resulting as 3350 u/ml. The results from the architect analyzer were believed to be correct. The patient was not adversely affected. The e170 analyzer serial number was (b)(4). The field service representative ran performance testing.
 
Manufacturer Narrative
Investigations conclude that ca 19-9 values can vary when measuring the same sample with different methods. This limitation is covered in product labeling.
 
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Brand NameELECSYS CA 19-9
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 Key5741144
MDR Text Key47909247
Report Number1823260-2016-00793
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050231
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Catalogue Number11776193122
Device Lot Number18863203
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2016
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

Patient Treatment Data
Date Received: 06/22/2016 Patient Sequence Number: 1
Treatment
METFORMIN (GLUCOPHAGE)
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