MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOTAL BHCG (5TH IS) REAGENT

Model Number	A85264
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Describe event or problem.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.

• Brand Name: ACCESS TOTAL BHCG (5TH IS) REAGENT
• Common Device Name: ACCESS TOTAL BHCG (5TH IS)
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 7953983
• Report Number: 2122870-2018-01022
• Device Sequence Number: 16250419
• Product Code: DHA
• UDI-Device Identifier: 15099590226213
• UDI-Public: (01)15099590226213(17)181130(11)171130(10)724349
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: A85264
• Device Catalogue Number: A85264
• Device Lot Number: 724349
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33