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	05/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: the full patient identifier is (b)(6).Sex, weight, and ethnicity: the customer did not supply patient demographics such as date of birth, sex, weight, ethnicity or race.Device evaluated by mfr: a beckman coulter laboratory solution specialist (lss) was dispatched on customer's site to perform interference testing.Patient sample was first tested neat for the accutni+3 assay.The lss obtained a high accutni+3 result.Customer's results were therefore confirmed.An interference testing, using different blockers, was then carried out.Polymak 33, hbr-1, goat, mouse and bovine iggs which are animal derived antibodies were tested and blocker related to alkaline phosphatase, was also tested.Interference antibodies interaction are listed in the limitations section of the accutni+3 instructions for use.This interference testing demonstrated the presence of interfering substances since the addition of hbr-1 blocker significantly lowered the signal.Per the access accutni+3 for use on unicel dxi systems instructions for use part number b00495 m, it states "for assays employing antibodies, the possibility exists for interference by heterophile antibodies in the patient sample.Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e.G.Hama, that interfere with immunoassays.Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in patient samples.Such interfering antibodies may cause erroneous results.Carefully evaluate the results of patients suspected of having these antibodies." in conclusion, the investigation demonstrated that heterophile interference is the cause of the falsely elevated accutni+3 patient results.
Event or Problem Description
On (b)(6) 2021, the customer reported obtaining reproducible false elevated troponin i (access accutni+3, part number a98264 and lot number 922065) results for one patient involving the laboratory's unicel dxi 800 access immunoassay analyzer (part number 973100 and serial number (b)(4)).The initial accutni+3 patient result was >84 ng/ml (the myocardial infarction (mi) cutoff is 0.03 ng/ml) while ecg (electrocardiogram) result was normal and other cardiac assays (ck-mb, ck and myoglobin) results were within the normal reference ranges and discordant with the accutni+3 results obtained.The customer recentrifuged the sample and retested it with the same result of >84 ng/ml.The initial and the recentrifuged sample were also tested with the hstni assay with expected normal results (0.0089 ng/ml and 0.0078 ng/ml) and on an alternate methodology (radiometer) with acceptable normal results which were also discordant with the access accutni+3 results (data not provided).The customer reported that the patient surgery (cholecystectomy) was suspended and delayed for about half a day due to the false high accutni+3 results.No system check, no quality control and no calibration data were provided.No hardware errors or other assay issues were reported in conjunction with this event.No issues with sample integrity were reported by the customer.A laboratory solution specialist was dispatched to the customer site and performed interference testing.

• 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: 11921446
• Report Number: 2122870-2021-00074
• Device Sequence Number: 948570
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)210731(11)200731(10)922065
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 07/31/2021
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 922065
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/02/2021
• 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
• Patient Age: 57 YR