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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER ACCESS AFP ALPHA-FETOPROTEIN KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

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BECKMAN COULTER ACCESS AFP ALPHA-FETOPROTEIN KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER Back to Search Results
Catalog Number 33210
Device Problem High Test Results (2457)
Patient Problem No Code Available (3191)
Event Date 09/15/2018
Event Type  Injury  
Manufacturer Narrative
The patients¿ demographics such as age, date of birth, sex, weight, ethnicity and race were not supplied. The lot number of the reagent was not provided. Information on the expiration date, date of manufacture and udi cannot be determined. The access afp reagent was not returned for evaluation. The customer reported that quality control, calibration and system check were all performing within specifications. The access afp results of other samples and the results of all other tests were transmitted and received by the lis correctly. There were no hardware errors or issues with other results reported in conjunction with this event. The beckman coulter field service engineer (fse) and laboratory system support (lss) dispatched to the customer's site did not identify any hardware, software, reagent or system issues that would have contributed to this event. The fse was unable to reproduce this event. Re-transmission of the initial access afp result was sent and received with no errors. The cause of this isolated event cannot be determined.
 
Event Description
The customer contacted beckman coulter on (b)(6) 2018 to report elevated alpha-fetoprotein (access afp) results for one patient sample. The result was generated on the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)) and recovered at 3. 45 ng/ml. The customer¿s reference range is 0. 0 ¿ 13. 4 ng/ml. The customer¿s laboratory information system (lis) recorded an elevated result of 345 ng/ml. The elevated access afp result was released from the lis and the report was sent to the patient. There was a change in patient care attributable to the elevated access afp result as the patient was admitted to a hospital and received treatment. The details of the treatment were not provided. The results of the testing in the hospital were reported to be normal. The customer did not report any additional change or impact to patient care or treatment in association with this event. The customer reported that quality control (qc), calibration and system check were performing within assay and instrument specifications at the time of the event. Information on the collection and processing of the patient sample is not available. No issues with sample integrity were reported.
 
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Brand NameACCESS AFP ALPHA-FETOPROTEIN
Type of DeviceKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Manufacturer (Section D)
BECKMAN COULTER
1000 lake hazeltine drive
chaska MN 55318
Manufacturer (Section G)
BECKMAN COULTER
1000 lake hazeltine drive
chaska MN 55318
Manufacturer Contact
david davis
250 s. kraemer blvd.
brea, CA 92821
7149613796
MDR Report Key8060137
MDR Text Key126896232
Report Number2122870-2018-01031
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K981354
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 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number33210
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/19/2018
Event Location No Information
Date Manufacturer Received10/19/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/12/2018 Patient Sequence Number: 1
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