MAUDE Adverse Event Report: BECKMAN COULTER ACCESS INHIBIN A REAGENT; ENZYME IMMUNOASSAY, INHIBIN-A

Model Number	A36097
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full identifier for this event is (b)(6).The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.The access inhibin a reagent was not returned for evaluation.No hardware errors were reported in conjunction with this event.The customer noted issues with system check failing on (b)(6) 2021 but was able to obtain a successful system check without any interventions noted by the customer.A precision run performed by the customer on (b)(6) 2021 passed within specifications; system hardware was verified.Customer provided data demonstrates a malfunction of imprecision for several samples.The imprecision demonstrated exceeds specifications which are found in the access inhibin a instructions for use (ifu): pn a83946 g this assay exhibits total imprecision = 8% at concentrations greater than 30 pg/ml see attached data for reference.Customer technical specialist discussed instrument maintenance with customer.Cts also verified reagent storage and inhibin a sample stability with customer.In conclusion, a cause for the imprecision malfunction cannot be determined with the available information.
Event or Problem Description
On 29march2021 the customer reported that on (b)(6) 2021, erroneous low inhibin a (access inhibin a, part number a36097 and lot number 922981) results were generated on the customer's access 2 (access 2 immunoassay analyzer, serial number (b)(4)) for several patients.Customer did not indicate whether the erroneous inhibin a results were released from the laboratory.The customer did not report injury or change to patient treatment as a result of the erroneous inhibin a results.System performance indicators such as calibration and quality control were passing within specifications at the time of the event.Although the customer reported issues with the system check, passing system check was obtained after failing system check with no indication of interventions performed by customer.Samples were collected offsite in 12x75mm serum separator tubes; other sample handling information such as sample clotting time and centrifugation speed and time were not provided.Customer noted the samples were aliquoted and frozen for transportation and thawed and tested upon receipt to the laboratory.

• Brand Name: ACCESS INHIBIN A REAGENT
• Common Device Name: ENZYME IMMUNOASSAY, INHIBIN-A
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11721842
• Report Number: 2122870-2021-00049
• Device Sequence Number: 3972075
• Product Code: NDR
• UDI-Device Identifier: 15099590203047
• UDI-Public: (01)15099590203047(17)211231(11)201231(10)
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K002128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: A36097
• Device Catalogue Number: A36097
• Device Lot Number: 922981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1