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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER ACCESS AFP REAGENT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER

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BECKMAN COULTER ACCESS AFP REAGENT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER Back to Search Results
Catalog Number 33211
Device Problem Low Test Results (2458)
Patient Problem No Code Available (3191)
Event Date 08/27/2018
Event Type  Injury  
Manufacturer Narrative
Patient demographics such as weight, race and ethnicity were not supplied. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance. The fse inspected the instrument's analytical module and removed and cleaned the wash wheel. Additionally, the sample probe was replaced as it appeared to be "slightly bent". Other proactive measures were taken to ensure instrument reliability including replacing the wash wheel bearings, the ejector plate sensor and the mixer motor. Lastly, the wash tower was cleaned and alignments adjusted/verified. The instrument's performance was verified through system check, hs (high sensitivity) system check, precision testing and carryover testing. All verification testing passed within published performance specifications. The fse did not note any hardware issues which would have contributed to this incident. The root cause of the low reproductive results (access inhibin a, access total bhcg ((5th is), access ue3 and access afp)) could not be determined with the information supplied.
 
Event Description
The customer reported obtaining low reproductive testing results including inhibin a (access inhibin a), beta human chorionic gonadotropin (access total bhcg (5th is)), unconjugated estriol (access ue3) and alpha-fetoprotein (access afp) for one (1) patient involving the unicel dxi 800 access clinical system serial number (b)(4). The customer reanalyzed the patient's sample on the same unicel dxi 800 access clinical system two (2) additional times and obtained reproducible, higher results. The initial low results were released from the laboratory. The patient in question underwent an amniocentesis to rule out trisomy 18 due to the low results obtained. The results of that testing were normal. There was no additional injury or report of death associated with this incident. Quality control (qc) and calibrations were performing within the assay's specifications at the time of the incident. There were no error messages posted to the event log at the time of the event. The customer did not provide specific information regarding the collection of the patient's sample. Centrifugation time and speed were not supplied by the customer for this incident. No issues with sample integrity were reported by the customer. Service was requested by the customer and a beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument's performance.
 
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Brand NameACCESS AFP REAGENT
Type of DeviceACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER
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 92821-8000
7149613796
MDR Report Key7953973
MDR Text Key123361374
Report Number2122870-2018-01020
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeCA
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 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number33211
Device Lot Number724409
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/19/2018
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/06/2017
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: 10/10/2018 Patient Sequence Number: 1
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