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	No Code Available (3191)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access accutni +3 reagent was not returned for evaluation.All assay and system verifications met specifications at the time of the event.No hardware errors, flags or other assay issues were reported in conjunction with this event.The cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2019, the customer reported that a non-reproducible elevated troponin i (access accutni+3) result had been generated on the customer's unicel dxi 600 immunoassay system (part number a30260 and serial number (b)(4)) for one patient sample.The initial elevated result of 0.23 ng/ml was released from the laboratory.The patient was drawn for additional troponin i testing; the result was 0.01 ng/ml.The emergency department (ed) called the lab questioning the first result of 0.23 ng/ml when the normal result (0.01 ng/ml) obtained from testing the second sample was received.The customer retested the first sample on the event analyzer and obtained a result of 0.00 ng/ml.On (b)(6) 2019, both samples were tested on a second dxi 600 analyzer, part number: a30260 and serial number: (b)(4).The first sample result was 0.00 ng/ml and the second sample result was 0.01ng/ml.Both samples were retested on the event analyzer; the first sample repeat result was 0.00 ng/ml and the second sample repeat result was 0.01 ng/ml.Customer provided reference range is 0.00 ng/ml - 0.04 ng/ml.There was a report of change to patient treatment or management which occurred in connection with this event.Due to the initial elevated troponin i result, the patient was scheduled to go to a catheterization lab offsite.The customer did not know if catheterization was performed.No further information regarding patient treatment our outcome was provided.Customer reported the sample was lithium a heparin plasma sample with adequate volume.No other sample processing 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: 8789699
• Report Number: 2122870-2019-01091
• Device Sequence Number: 2639215
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)200331(11)190401(10)920722
• 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): 07/15/2019

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: 03/31/2020
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 920722
• Distributor Facility Aware Date: 06/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other