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

Catalog Number	A85264
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics such as age, date of birth, weight, race and ethnicity were not supplied.(b)(6).A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's laboratory to assess instrument performance as the customer was not questioning the performance in conjunction with this event.All of the system parameters, including quality controls (qc), calibrations, system checks and precision run were performing with instrument specifications at the time of the event.The access total bhcg (5th is) reagent was not returned to bec for further investigation.No further information is available regarding the performance of the reagent.There were no reports of error messages, system flags or issues with other patients/assays in conjunction with this event.In conclusion, the cause of this event could not be determined with the information supplied.
Event or Problem Description
The customer reported obtaining a non-reproducible low (normal) beta human chorionic gonadotropin (access total bhcg (5th is)) result for one (1) patient on the laboratory's access 2 immunoassay system serial (b)(4).The initial access total bhcg (5th is) result obtained on (b)(6) 2017 was within the normal reference range of the assay which indicated that the patient was not pregnant.On (b)(6) 2017 the patient's sample was reanalyzed on the original access 2 immunoassay system and a significantly higher result, in a different gestational category (i.E.For a pregnant female), was obtained.In addition, a second sample was also analyzed for access total bhcg (5th is) on the original access 2 immunoassay system the same day ((b)(6) 2017) and similar elevated results were obtained.The initial low access total bhcg (5th is) result was released from the laboratory.Subsequently, there was a change in patient treatment/management as the patient had taken the following medications; dexamethasone, metamizole and bufferin cold tablets prior to knowing that they were pregnant.System performance indicators such as assay quality control (qc), calibrations, system checks and precision testing were all performing within the assay/instrument's specifications at the time of the event.There were no indications of hardware issues, system flags or issues with other assays in conjunction with this event.The customer did not provide sample collection or processing information such as centrifugation time and speed in regards to this event.There were no indications of sample integrity issues in association with this event.
Additional Manufacturer Narrative
A beckman coulter (bec) field service engineer (fse) was dispatched to the customer's laboratory to assess instrument performance.No instrument issues were identified during the fse's visit.

• 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 MN 55318
• MDR Report Key: 6858716
• Report Number: 2122870-2017-00044
• Device Sequence Number: 16286067
• Product Code: DHA
• UDI-Device Identifier: 15099590226213
• UDI-Public: (01)15099590226213(17)171031(11)161122(10)631415
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 08/18/2017

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: 10/31/2017
• Device Catalogue Number: A85264
• Device Lot Number: 631415
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 11/14/2017
• 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