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	02/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is (b)(4).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.A beckman coulter local support assisted the customer with verifying the system performance.From (b)(6) to (b)(6) 2022, the customer ran test samples in duplicate as part of troubleshooting.The customer provided six (6) test samples results using reagent pack serial number (b)(4) and (b)(4), which were also non-reproducible: test sample one : initial result 155.3 pg/ml repeated at 6.6 pg/ml.Test sample two : initial result 2262.2 pg/ml repeated at 5.2 pg/ml.Test sample three : initial result 1764.4 pg/ml repeated at 2.5 pg/ml.Test sample four : initial result 972.6 pg/ml repeated at 37.78 pg/ml.Test sample five : initial result 47.71 pg/ml repeated at 9.75 pg/ml.Test sample six : initial result 70.97 pg/ml repeated at 21.03 pg/ml.The non-reproducible tnidx recovery was not observed in quality control samples run on pack serial number (b)(4) or other serial numbers.Running tnidx qc (quality control) recovery with consistent results obtained was reported to recover at <6 %cv (percent coefficient of variation).System performance indicators of high sensitivity system check, system check, carryover and tnidx precision studies (using reagent pack serial numbers (b)(4) and (b)(4)) were run on (b)(6) 2022.All passed within beckman coulter specifications and did not demonstrate an issue with the system.Additional testing on the reagent pack serial numbers (b)(4) and (b)(4) could not be performed as no remaining product was available for testing.Per communication with local support, no abnormalities were observed with reagent packs.Two retain packs of tnia2 lot 124617 were visually inspected by complaint investigator on (b)(6) 2022.The packs were unremarkable upon visual inspection.No precipitate was observed in the retain reagent packs.On (b)(6) 2022, the most recent three months ((b)(6) 2021, (b)(6) 2021, (b)(6) 2021) of completed immunoassay complaint handling unit trending workbooks were reviewed by complaint investigator.No complaint trending triggers were identified for accutni+3 reagent lot a98264 involving reagent lot number 124617.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) 2022 the customer reported obtaining one non-reproducible falsely elevated troponin i (access accutni+3) result for one patient involving the laboratory's unicel dxi 800 access immunoassay analyzer (serial number (b)(4)).On (b)(6) 2022 the initial tnidx patient result was 838.8 pg/ml.The sample was repeated twice with the following lower results: 4.0 pg/ml and 3.7 pg/ml.All three sample replicates were run on the reagent pack lot 124617, pack serial number (b)(4).The customer reported the patient received cardiac catheter ablation treatment due to the falsely elevated tnidx result.Beckman coulter local support assisted the customer with verifying the system performance.From (b)(6) to (b)(6) 2022, the customer ran test samples in duplicate as part of troubleshooting.The customer provided six (6) test samples results using reagent pack serial number 499 and 7562, which were also non-reproducible: test sample one: initial result 155.3 pg/ml repeated at 6.6 pg/ml.Test sample two: initial result 2262.2 pg/ml repeated at 5.2 pg/ml.Test sample three: initial result 1764.4 pg/ml repeated at 2.5 pg/ml.Test sample four: initial result 972.6 pg/ml repeated at 37.78 pg/ml.Test sample five : initial result 47.71 pg/ml repeated at 9.75 pg/ml.Test sample six : initial result 70.97 pg/ml repeated at 21.03 pg/ml.The non-reproducible tnidx recovery was not observed in quality control (qc) samples.Tnidx qc was run across multiple reagent pack serial numbers with consistent results obtained.Running qc recovery was reported to recover at <6 %cv (percent coefficient of variation).System performance indicators of high sensitivity system check, system check, carryover and tnidx precision studies (using reagent pack serial numbers (b)(4) and (b)(4)) were run on (b)(6) 2022.All passed within beckman coulter specifications and did not demonstrate an issue with the system.Per communication with local support, no abnormalities were observed with reagent packs.The patient sample was serum.There were no issues with sample integrity reported by the customer, no fibrin or particulate matter was observed.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.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
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 13618566
• Report Number: 2122870-2022-00011
• Device Sequence Number: 5644112
• Product Code: MMI
• UDI-Device Identifier: 15099590209353
• UDI-Public: (01)15099590209353(17)220630(11)210630(10)124617
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

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: 06/30/2022
• Device Model Number: A98264
• Device Catalogue Number: A98264
• Device Lot Number: 124617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown