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	Misdiagnosis (2159)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is case-(b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.Access accutni+3 reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.A beckman laboratory solution specialist (lss) was dispatched to the customer site.The lss first tested the patient sample neat for the accutni+3 assay and obtained a similar high result at 25.56 ng/ml.An interference testing, using different blockers, was then carried out.The blockers used in the interference testing consist of polymak 33, hbr-1, goat, mouse and bovine iggs which are animal derived antibodies.A pool of blockers related to alkaline phosphatase (scav-alp + ap mutein pool), 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 access accutni+3 instructions for use, ¿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 results.
Event or Problem Description
On (b)(6) 2020 the customer reported obtaining reproducible erroneously high troponin i (access accutni+3) results for one patient involving the laboratory's unicel dxi 800 access immunoassay analyzer (serial number (b)(4)).On (b)(6) 2020, one accutni+3 patient sample result was 29.48 ng/ml which was above the customer's reference range (0-0.03 ng/ml).The repeat result was still high at 29.72 ng/ml.A coronary angiography was then performed due to the elevated access accutni+3 result, which was normal.The sample was also tested with the roche tnt assay (0.006 ng/ml) and the xingtong medical technology with both normal results (no further information provided).On (b)(6) 2020 the sample was also tested with the access hstni assay.The result was normal at 4.095 pg/ml.A coronary angiography was performed due to the elevated access accutni+3 results.There was no additional change to or impact to patient care reported in association with this incident.On (b)(6) 2020, a beckman laboratory solution specialist (lss) was dispatched to the customer site.The lss first tested the patient sample neat for the accutni+3 assay and obtained a similar high result at 25.56 ng/ml.An interference testing, using different blockers, was then carried out.The blockers used in the interference testing consist of polymak 33, hbr-1, goat, mouse and bovine iggs which are animal derived antibodies.A pool of blockers related to alkaline phosphatase (scav-alp + ap mutein pool), 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.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.

• 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: 10670168
• Report Number: 2122870-2020-00087
• Device Sequence Number: 19518972
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)201231(11)200101(10)921411
• 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): 10/13/2020

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: 12/31/2020
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 921411
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/13/2020
• 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