MAUDE Adverse Event Report: BECKMAN COULTER ACCESS AFP; KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Catalog Number 33211

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access afp reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.A beckman coulter laboratory support specialist (lss) was dispatched to the customer site; while onsite, the lss performed interference testing on the sample.Lss testing of the neat sample produced an elevated result that confirmed the customer's result.Interference testing was then performed using alp blockers, hbr-1, mouse igg, bovine igg, rabbit igg and goat igg.Signal of the sample was not reduced using any of these blockers, and the lss testing did not confirm presence of any of these interferents in the patient sample.There is evidence of a malfunction of discordance as the patient's sample was discordant to a competitor platform, pet-ct scan and the patient's clinical profile.The cause of the malfunction cannot be determined with the available information.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2021 the customer reported erroneous reproducible elevated afp (access afp, part number 33211 and lot number 922780) were generated on the customer's dxi (unicel dxi 800 access immunoassay analyzer, part number 973100 and serial number (b)(4)) for one patient.The afp result of 153.6 ng/ml was released from the laboratory.There was a report of change to patient care or management which occurred in connection with this event.The patient underwent a pet-ct scan.The pet-ct scan did not show any tumors.The sample was repeat tested and results of 151.22 ng/ml and 167.98 ng/ml were obtained.The sample was then diluted and a result of 174.63 ng/ml was obtained.A second sample was collected from the patient.The second sample was tested using the abbott platform and a result of 8 ng/ml was obtained.This result was in alignment with the patient's clinical profile and the pet-ct scan results.The first sample collected was then tested on the abbott platform and a result of 3.65 ng/ml was obtained.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 collection, handling and processing information such as sample type, collection tube used, centrifugation time and speed, sample storage or other information was not provided by the customer.

• Brand Name: ACCESS AFP
• Type of Device: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR 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: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12342799
• MDR Text Key: 267290232
• Report Number: 2122870-2021-00130
• Device Sequence Number: 1
• Product Code: LOJ
• UDI-Device Identifier: 15099590231491
• UDI-Public: (01)15099590231491(17)220531(11)201207(10)922780
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 33211
• Device Lot Number: 922780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other