MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TOTAL B- HCG; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	A85264
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 the customer reported an erroneous non-reproducible elevated bhcg (access total b- hcg, part number (b)(4) and lot number 124444) was generated on the customer's access 2 (access 2 immunoassay analyzer, part number (b)(4) and serial number (b)(4)) on (b)(6) 2021.The erroneous elevated bhcg result of 354.31 miu/ml was reported to the ordering physician who questioned the result as not matching the expected clinical diagnosis; the physician requested the sample to be retested for bhcg.The sample was retested on (b)(6) 2021 on access 2 serial number (b)(4) and an alternate access 2, serial number (b)(4) and lower results (0.03 miu/ml and 0.05 miu/ml, respectively) were obtained.The customer also reported that the patient was redrawn on 05nov2021 and 07nov2021 and lower bhcg results were obtained (results of these redraws were not provided for review).There was a report of change to patient treatment or management in connection with this event.A written attempt was made to obtain additional information regarding change to treatment; however, the customer reported they did not know what patient treatment was performed in connection with this event.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.Sample was a heparinized plasma, noted to be clean with no evidence of fibrin or clots.Sample collection, processing and storage information were not provided by the customer.
Additional Manufacturer Narrative
The full patient identifier for this event is (b)(4).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity and race.The access total b- hcg reagent was not returned for evaluation.System performance indicators of passing system checks and quality control recovery did not demonstrate an issue with the system.Beckman coulter customer technical support (cts) assisted the customer in performing hardware verification.Review of customer provided data shows the customer performed a 15 replicate precision study which recovered within specifications.A beckman coulter field service engineer (fse) was dispatched to the customer site.On (b)(6) 2021 the fse performed a preventative maintenance (pm) on the access 2 instrument.There were no reports of issues observed during the pm.In conclusion, the cause of the event cannot be determined with the available information.

• Brand Name: ACCESS TOTAL B- HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12861193
• Report Number: 2122870-2021-00173
• Device Sequence Number: 4205624
• Product Code: DHA
• UDI-Device Identifier: 15099590226213
• UDI-Public: (01)15099590226213(17)220630(11)210630(10)124444
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 06/30/2022
• Device Model Number: A85264
• Device Catalogue Number: A85264
• Device Lot Number: 124444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown