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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS AFP ASSAY KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

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ROCHE DIAGNOSTICS ELECSYS AFP ASSAY KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER Back to Search Results
Model Number AFP
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2019
Event Type  malfunction  
Manufacturer Narrative
The reporter cleaned and primed the sample probe. After this, controls were measured with the complained reagent pack. No alarms occurred, but measurement results were all < 0. 605 ng/ml. The investigation could not identify a product problem. The cause of the event could not be determined. This event occurred in (b)(6).
 
Event Description
The initial reporter stated they received discrepant results for two patient samples tested with the elecsys afp assay on a cobas e 411 immunoassay analyzer. It was asked, but it is not known if any incorrect values were reported outside of the laboratory. A sample probe alarm was generated when using the afp reagent pack and samples were remeasured after replacement of the pack. The repeat values were believed to be correct. The first sample initially resulted with an afp value of < 0. 605 ng/ml and upon repeat, the sample resulted with a value of 6. 29 ng/ml. The second sample initially resulted with an afp value of < 0. 605 ng/ml and upon repeat, the sample resulted with a value of 2. 88 ng/ml. The e 411 analyzer serial number is (b)(4).
 
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Brand NameELECSYS AFP ASSAY
Type of DeviceKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
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 Key9526135
MDR Text Key219778606
Report Number1823260-2019-04552
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K981282
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
Report Date 12/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAFP
Device Catalogue Number04481798190
Device Lot NumberASKU
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 Received12/12/2019
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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