MAUDE Adverse Event Report: BECKMAN COULTER ACCESS GI MONITOR CANCER ANTIGEN 19-9; SYSTEM,TEST,CARBOHYDRATE ANTIGEN(CA19-9),FOR MONITOR,MANAGE OF PANCREATIC CANCER

Model Number	387687
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is (b)(6).The exact number of patients involved in this event was not specified.The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.Device evaluated by mfr: the access gi monitor reagent was not returned for evaluation.The reagent pack was discarded by customer.No hardware errors or issues with other assays were reported in conjunction with this event.A beckman coulter laboratory solution specialist (lss) was dispatched to customer's site.The lss checked the instrument and found that only pipettor 2 was used with the access gi monitor assay.A deviation between pipettors was ruled out.No ncr (non conformance report) had been reported with reagent lot 125013.The lss recommended to the customer following the access gi monitor instructions for use ifu "mix contents of new (unpunctured) reagent packs by gently inverting pack several times before loading on the instrument.Do not invert open (punctured) packs." in conclusion, a cause for this event could not be determined with the information supplied.There is no evidence of a reagent or system malfunction.
Event or Problem Description
On (b)(6) 2022 the customer reported obtaining non-reproducible false elevated access gi monitor (ca 19-9) (lot number 125013) results involving the laboratory's unicel dxi 800 access immuno analyzer (serial number (b)(4).The exact number of patients involved in this event was not specified.The customer reported that on (b)(6) 2022, multiple patients samples results were around 200 u/ml (around last twenty tests of the reagent pack 8600).The elevated patient samples were rechecked with lower results.(no data provided).The customer also rechecked other samples tested with different reagent packs before and after the questioned one.The results were as expected.The expected values for the gi monitor (ca 19.9) assay are < 35 u/ml.The customer reported some patients were ordered a contrast enhanced computed tomography because of the high access gi monitor results.No additional impact or change to patient treatment was reported in connection with the event.No hardware errors or issues with other assays were reported in conjunction with this event.System check passed on 6jul2022.Calibration passed on 7jul2022 using reagent lot 125013 and calibrator lot 124563.Quality control at the time of the event was not provided for review.A beckman coulter laboratory solution specialist (lss) was dispatched to customer's site.There were no issues with sample integrity reported by the customer.No further sample information was provided.

• Brand Name: ACCESS GI MONITOR CANCER ANTIGEN 19-9
• Common Device Name: SYSTEM,TEST,CARBOHYDRATE ANTIGEN(CA19-9),FOR MONITOR,MANAGE OF PANCREATIC CANCER
• 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: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 15049658
• Report Number: 2122870-2022-00034
• Device Sequence Number: 5338633
• Product Code: NIG
• UDI-Device Identifier: 15099590231842
• UDI-Public: (01)15099590231842(17)220930(11)210930(10)125013
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2022

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: 09/30/2022
• Device Model Number: 387687
• Device Catalogue Number: 387687
• Device Lot Number: 125013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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