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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AFP ¿1-FETOPROTEIN KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

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ROCHE DIAGNOSTICS AFP ¿1-FETOPROTEIN KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER Back to Search Results
Catalog Number 04481798190
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2016
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer reported in medwatch report 1823260-2016-00703-00, customer a, had issues with tests for afp a1-fetoprotein (afp) since (b)(6) 2016 when they changed to new reagent lot. During troubleshooting of this issue, patient samples were tested at multiple sites on roche analyzers. As reported in follow up report 1823260-2016-00703-01, the investigation determined the customer's results as reported in mdr 1823260-2016-00703-00 were determined to be correct and there may be a potential issue at one of the sites where comparison testing was performed. This medwatch report is for the site identified as having potential issues, which will be referred to as customer b in this report. Data was provided for 62 patient samples that were tested for afp at customer b compared to customer a. Based on the data provided, the results for 10 patient samples were erroneous. The afp results from customer b were reported outside of the laboratory. Customer a also ran 26 patient samples on roche analyzers at 4 different hospital sites to troubleshoot the issue with the afp test. Based on the results from the multiple comparisons performed, erroneous results for 4 patient samples were generated from customer b. The results from the other 3 hospital sites were comparable to one another. It is unclear whether the comparison data was being used for troubleshooting purposes only or if the afp results from customer b were reported outside of the laboratory for diagnostic purposes. No adverse event occurred. The e602 analyzer serial number was (b)(4).
 
Manufacturer Narrative
It was clarified that the results from customer b were in a different unit of measure than the results from customer a. Customer a was reporting afp results in iu/ml. Customer b was reporting afp results in ug/l.
 
Manufacturer Narrative
Based on the recalculated data provided by the customer in a previous follow-up report, the afp results between customer a and customer b were comparable to one another. Due to this, the investigation stated any false interpretation of results can be excluded. The data provided confirm that the initial differences between the afp results from customer a and customer b were due to an operator error. Customer a was reporting afp results in iu/ml. Customer b was reporting afp results in ug/l. The operators did not notice that the afp results for each site were in different units of measure. Once the conversion factor was applied to the results, the issue with afp results was corrected.
 
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Brand NameAFP ¿1-FETOPROTEIN
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 Key5815708
MDR Text Key50300698
Report Number1823260-2016-01041
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K981282
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04481798190
Device Lot Number133108
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 Received07/06/2016
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

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