MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOTAL BHCG (5TH IS); SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number	A85264
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not supply patient demographics such as age, date of birth or weight.(b)(6).A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site.No hardware errors, flags or other assay issues were reported in conjunction with this event.There is no evidence that the access total bhcg (5th is) reagent was returned for evaluation.One sample was sent to the beckman coulter complaint handling unit.The patient sample was analyzed on the access 2 immunoassay system serial number (b)(4), and recovered with an access total bhcg (5th is) result above the highest calibrator value.This result confirmed the results obtained by the customer.Dilution testing generated linear results.Interference testing was performed.The sample recovered similarly and above the highest calibrator value.The investigation could not demonstrate any interference.In conclusion, the cause of the event cannot be determined with the available information.
Event or Problem Description
The customer reported obtaining a reproducible elevated total beta human chorionic gonadotropin (access total bhcg (5th is)) result for one (1) patient involving the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)).The customer reanalyzed the patient's sample once with the onboard dilution feature and once with the special dilution feature and generated elevated results, above the expected values for the patient's gestational age.A new sample from the same patient was collected and analyzed on the same laboratory's unicel dxi 800 access immunoassay system and a similar result above the assay's highest calibrator value was obtained.The customer reanalyzed the patient's sample once with the onboard dilution feature and generated an elevated result, above the expected values for the patient's gestational age.The elevated access total bhcg (5th is) result was not released from the laboratory.There was no report of patient injury or change in patient treatment associated with this event.Calibration, qc (quality control) and system check parameters were all recovering within expected ranges at the time of the event.The patient's sample was collected in a becton dickinson serum tube and was centrifuged at 1,800 g (g-force) for ten (10) minutes at an unknown temperature.No issues with sample integrity were reported by the customer.

• Brand Name: ACCESS TOTAL BHCG (5TH IS)
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska 55318
• MDR Report Key: 5983885
• Report Number: 2122870-2016-00462
• Device Sequence Number: 10786333
• Product Code: DHA
• UDI-Device Identifier: 15099590226213
• UDI-Public: (01)15099590226213(17)170430(11)160428(10)622964
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: A85264
• Device Lot Number: 622964
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Initial Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1