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

Catalog Number	A36097
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The access inhibin a reagent was not returned for evaluation.A beckman coulter field service engineer was not dispatched to the customer's site.There is no evidence to reasonably suggest a system malfunction; system parameters (calibrations and qc) met assay and instrument specifications.There were no indications of instrument error messages at the time of the event.The customer attributed the erroneous results to fibrin in one of the patient samples.Per clinical and laboratory standards institute (clsi) guideline-gp44-a4: procedures for the handling and processing of blood specimens for common laboratory tests.Fourth edition, "residual fibrin, a possible interferent in the clinical laboratory, may occur secondary to improper specimen handling during or after collection.Fibrin may directly affect some assays.Fibrin interference is usually not reproducible." the customer declined to perform hardware troubleshooting.In conclusion although sample integrity may have contributed to this event, an assignable cause could not be determined with the information provided.
Event or Problem Description
The customer reported obtaining non-reproducible, low dimeric inhibin a (access inhibin a) results for four patient samples on the laboratory's unicel dxi 600 access immunoassay system (serial number (b)(4)).The initial results were lower than the customer expected.The customer was analyzing the samples as part of a maternal screen which included alpha-fetoprotein (access afp) unconjugated estriol (access unconjugated estriol) beta human chorionic gonadotropin (access total bhcg (5th is)) and access inhibin a.The initial results from the four assays recovered below the customer's expectations for the four patient samples.An additional seven patient samples analyzed at the same time recovered with initial results below the customer's expectations.The initial results were not released from the laboratory.There was no change to patient care or treatment which occurred in association with non-reproducible access patient results.The patients' samples were reanalyzed on the same unicel dxi 600 access immunoassay system and recovered with higher results, within the customer's expected values.Calibrations and quality control (qc) were performing within assay and instrument specifications at the time of the event.There were no hardware errors reported in conjunction with this event.The samples were collected in serum separator tubes.Information on centrifugation time, speed and temperature was not provided.The customer identified fibrin in one of the patient's samples.

• Brand Name: ACCESS INHIBIN A
• Common Device Name: ENZYME IMMUNOASSAY, INHIBIN-A
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 7148746
• Report Number: 2122870-2017-00059
• Device Sequence Number: 16167224
• Product Code: NDR
• UDI-Device Identifier: 15099590203047
• UDI-Public: (01)15099590203047(17)180531(11)170606(10)723809
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/05/2017

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: 05/31/2018
• Device Catalogue Number: A36097
• Device Lot Number: 723809
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR