MAUDE Adverse Event Report: BECKMAN COULTER ACCESS ACCUTNI+3 REAGENT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	A98264
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access accutni+3 reagent was not returned for evaluation.Available system performance indicators of overall passing system check, precision studies and quality control recovery did not demonstrate an issue with the system.Although a failing system check was obtained on (b)(6) 2021, there is insufficient evidence to suggest a hardware malfunction was the cause of this event.The failing system check was run sixteen (16) days after the event.Additionally, there were no reports of hardware interventions performed or hardware parts replaced to resolve the system check failure.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.The customer plans to run tnidx patient samples in duplicate.In conclusion, an assignable cause of the event cannot be determined with the available information.There is insufficient evidence to suggest a reagent or hardware malfunction occurred in this event.
Event or Problem Description
On (b)(6) 2021 the customer reported obtaining non-reproducible false high troponin i (access accutni+3) results for two samples from one patient involving the laboratory's unicel dxi 800 access immuno analyzer ((b)(4)).The elevated results (both at 0.18 ng/ml on (b)(6) 2021) were questioned by the ordering physician as a third draw from the patient was negative (0.00 ng/ml) for myocardial infarction.The customer repeated the tnidx results on same analyzer and lower results were obtained (all results were at 0.00 ng/ml).The patient was administered aspirin and given a ct (computerized tomography) scan.The ordering physician had ordered a ct scan of the head, neck, and chest.The patient started the ct scan of the head and neck but was unable to complete the chest ct.Multiple written attempt were made to obtain additional information regarding if contrast media was administered to the patient for the ct scan.No further information was provided.Calibration passed on (b)(6) 2021 using reagent lot 124536 and calibrator lot 922646.Quality control was within acceptable range.A passing system check was obtained on (b)(6) 2021.On (b)(6) 2021, the customer ran a system check which failed the washed portions.The customer repeated the system check with passing results.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.Sample tube collection type was a bd green top lihep tube.Customer reported that samples were centrifuged for 5 minutes at 5000-10000 rpm.There was no report of sample integrity issues.No further sample information was provided.

• Brand Name: ACCESS ACCUTNI+3 REAGENT
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12459653
• Report Number: 2122870-2021-00143
• Device Sequence Number: 11779140
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)220531(11)210531(10)124536
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121214
• 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): 09/13/2021

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: 05/31/2022
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 124536
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other