MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T HS; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 09315357190

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

The customer material (sample) was requested for investigation.

Event Description

The initial reporter received a questionable elecsys troponin t hs result for one patient sample tested with a cobas e 801 analytical unit.The initial troponin-t hs result, tested on a cobas e 801, was 5.93 pg/ml.The repeat result, tested on another laboratory on a cobas e 601, was 7 pg/ml.The initial troponin-i result (from abbott) was requested but not provided, it was alleged that the result was above the cutoff of 34.2 pg/ml.The repeated result was tested on an aliquot of the same blood draw and the result was 137.2 pg/ml.The cobas e 601 serial number was requested but not provided.The cobas e 801 serial number is (b)(4).The troponin-i was measured on the alinity abbott instrument.The results were reported outside of the laboratory.The comparison of the negative troponin t result with the positive troponin i result is not expected from a clinical point of view.

Manufacturer Narrative

The investigation included measuring the patient's sample with a cobas e 801.The following results were obtained: ck-mb 2,25 ng/ml.Probnp 12,2 pg/ml.Tni 0,228 ng/ml.Tnt hs 6,21 pg/ml.Tsh 1,33 uiu/ml.All four assays were within the normal range, with no indication of a cardiac event.Also, tsh was within the normal range.The sample was further tested for interfering factors.The results of a serum fractionation did not show the presence of an interfering factor in the sample and therefore an interference in the sample with the elecsys troponin i assay could be excluded.The troponin t and troponin i value in the complaint sample measured with the elecsys assays appear to be true negative values.The investigation did not identify a product problem.The troponin t and troponin i value in the complaint sample measured with the elecsys assays are consistent with a true negative value.

• Brand Name: ELECSYS TROPONIN T HS
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15691347
• MDR Text Key: 304409553
• Report Number: 1823260-2022-03397
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K201441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 09315357190
• Device Lot Number: 56640901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/28/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1