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

Model Number	A98264
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
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.There is sufficient evidence to suggest an imprecision malfunction occurred as 3 or more replicates of the same sample on the same device recovered outside the expected assay precision.An assignable cause of the event cannot be determined with the available information.Although low level of qc recovered over 2 sd (standard deviations) below the customer¿s stated mean, all other system performance indicators of system check, calibration and precision studies did not demonstrate an issue with the system.No other patient results were called into question.The cause of the imprecision malfunction cannot be determined with the available information.
Event or Problem Description
On 06jul2020 the customer reported obtaining non-reproducible troponin i (access accutni+3) results for one patient involving the laboratory's unicel dxi 800 access immuno analyzer (serial number (b)(4)).The initial result was 2.75 ng/ml.The sample was repeated due to the initial value being above cutoff (0.03 ng/ml) at 9.43 ng/ml.Because of the poor reproducibility of the result, the sample was aliquoted, recentrifuged and retested with the following results: 1.57 ng/ml, 3.5 ng/ml, 1.65 ng/ml and 2.63 ng/ml.The sample was run on other dxi instrument and gave higher results of 5.8 ng/ml repeated at 6.34 ng/ml.Theses two results from other dxi analyzer were reported out of the laboratory.Customer reported the patient was believed to have acute mi (myocardial infarction).No affect to patients or end-users has been reported in connection with this event.Calibration, system checks and carryover passed within specifications.Calibrator lot was expired at the time of the event (expiration date: 30june2020).Before and after the event, level 1 qc (quality control) recovered over 2 sd (standard deviations) below the customer¿s stated mean.Level 2 and level 3 recovered within the 2 sd range as demonstrated in the attached data.Sample was drawn in a lithium heparin tube.The customer reported that the sample was centrifuged for 3 minutes at 5100 rpm [revolutions per minute].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: 10313187
• Report Number: 2122870-2020-00066
• Device Sequence Number: 2613175
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)210331(11)200331(10)921807
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 921807
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1