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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2016
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer has had issues with tests for afp a1-fetoprotein (afp) since (b)(6) 2016 when they changed to a new reagent lot. The previous afp reagent lot number was 187903. The new afp reagent lot number is 133108. The expiration dates were not provided. The customer was having issues with their quality control values and began to question the patient results. The customer sent 3 patient samples tested for afp to another hospital for testing. The results for all 3 patient samples were erroneous when compared to the instrument from the other hospital. The type of instrument was not provided. It is not known if any erroneous results were reported outside of the laboratory. Patient 1 initial result from the e602 analyzer was 75 iu/ml. The repeat result from the other hospital's instrument was 107 (unit of measure not provided). Patient 2 initial result from the e602 analyzer was 378 iu/ml. The repeat result from the other hospital's instrument was 570 (unit of measure not provided). Patient 3 initial result from the e602 analyzer was 420 iu/ml. The repeat result from the other hospital's instrument was 630 (unit of measure not provided). The customer has also sent the samples to a second hospital and indicated that the afp results from the second hospital were "very accurate. " the specific values were not provided. No adverse event occurred. The e602 analyzer serial number was (b)(4).
 
Manufacturer Narrative
The customer has been troubleshooting the roche afp assay with lot number 133108 by running patient samples on other roche analyzers at different hospital sites. The customer performed a method comparison with 26 patient samples and tested the samples for afp at the customer site and a 3rd hospital. The results were comparable. Since these results were comparable, the customer sent the samples to the "other hospital" mentioned in the initial report and a 4th hospital. The results from the 4th hospital were comparable to the results from the customer site. The results from the "other hospital" mentioned in the initial report were higher than the results from the customer site and the other 2 sites which indicates there may be an issue with afp tests at the "other hospital. " based on the results from the multiple comparisons performed and additional information provided for investigation, a general issue with the instrument and reagent can be excluded. No performance issues with afp were identified at the customer site.
 
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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 Key5691611
MDR Text Key46309265
Report Number1823260-2016-00703
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
Report Date 07/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2016
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 Received05/12/2016
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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