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

Catalog Number 05094810160

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 01/13/2022

Event Type  malfunction  

Event Description

The initial reporter received a questionable elecsys troponin i stat immunoassay result for one patient sample tested on a cobas 6000 e 601 module with serial number (b)(4).The reporter sent the sample to a partner laboratory for testing.This laboratory also uses a roche module.The initial result was reported outside of the laboratory.The physician did not agree with the result and further testing was performed in two external laboratories.The reporter mentioned three samples.Sample 1 was the initial sample and was sent to the partner laboratory.Sample 2 was sent to the first laboratory and sample 3 was sent to a second external laboratory.It was not clear if the samples tested in the two external laboratories was the initial sample.The reporter has not responded to an inquiry regarding the details of the samples tested in the external laboratories.On (b)(6) 2022, sample 1 had an initial result from the module was 0.131 ug/l.Sample 2 had a result of 1032.60 ng/l from the first external laboratory.On (b)(6) 2022, sample 3 had a result of 1223.31 ng/l from the second external laboratory.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

It was confirmed that the initial sample from the customer's partner laboratory was the sample that was sent out to the first and second external laboratories.The first external laboratory uses siemens equipment with an unknown laboratory method.The second external laboratory uses cerba international with immunochemilluminescence as the laboratory method.Medwatch fields b7 and d10 were updated.The investigation is ongoing.

Manufacturer Narrative

In mfr report ref #1823260-2022-00370-00, b5 - describe event or problem should have been: "the initial reporter received a questionable elecsys troponin i immunoassay result for one patient sample tested on a cobas 6000 e 601 module with serial number (b)(6).Instead of: "the initial reporter received a questionable elecsys troponin i stat immunoassay result for one patient sample tested on a cobas 6000 e 601 module with serial number (b)(6).Medwatch fields b7, d1 and d4 were updated.A sample from a second blood collection was received for investigation.Investigation result: troponin i = 0.129 ng/ml.The investigation is ongoing.

Manufacturer Narrative

In mfr report ref #1823260-2022-00370, b5 - describe event or problem should have been: "the initial reporter received a questionable elecsys troponin i stat immunoassay result for one patient sample tested on a cobas 6000 e 601 module with serial number (b)(6).The reporter sent the sample to a partner laboratory for testing.This laboratory also uses a roche module.The initial result was reported outside of the laboratory.The physician did not agree with the result and further testing was performed in two external laboratories.The reporter mentioned three samples.Sample 1 was the initial sample and was sent to the partner laboratory.Sample 2 was sent to the first laboratory and sample 3 was sent to a second external laboratory.It was not clear if the samples tested in the two external laboratories was the initial sample.The reporter has not responded to an inquiry regarding the details of the samples tested in the external laboratories.On 13-jan-2022, sample 1 had an initial result from the module was 0.131 ng/l.Sample 2 had a result of 1032.60 ng/l from the first external laboratory.On (b)(6) 2022, sample 3 had a result of 1223.31 ng/l from the second external laboratory." instead of: "the initial reporter received a questionable elecsys troponin i stat immunoassay result for one patient sample tested on a cobas 6000 e 601 module with serial number (b)(6).The reporter sent the sample to a partner laboratory for testing.This laboratory also uses a roche module.The initial result was reported outside of the laboratory.The physician did not agree with the result and further testing was performed in two external laboratories.The reporter mentioned three samples.Sample 1 was the initial sample and was sent to the partner laboratory.Sample 2 was sent to the first laboratory and sample 3 was sent to a second external laboratory.It was not clear if the samples tested in the two external laboratories was the initial sample.The reporter has not responded to an inquiry regarding the details of the samples tested in the external laboratories.On 13-jan-2022, sample 1 had an initial result from the module was 0.131 ug/l.Sample 2 had a result of 1032.60 ng/l from the first external laboratory.On (b)(6) 2022, sample 3 had a result of 1223.31 ng/l from the second external laboratory." the patient sample was tested by an external laboratory site for tni hs using an abbott alinity analyzer.The result was 106.6 pg/ml or 0.1066 ng/ml.The investigation laboratory was able to reproduce the original result.The result was also confirmed by a competitor analyzer (abbott alinity).The calibration and qc did not indicate an issue.Based on the information provided a product problem can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TROPONIN I IMMUNOASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13525243
• MDR Text Key: 292191454
• Report Number: 1823260-2022-00370
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 04015630939374
• UDI-Public: 04015630939374
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K082699
• 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,Followup,Followup
• Report Date: 05/09/2022

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 Catalogue Number: 05094810160
• Device Lot Number: 46011600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 02/17/2022; 03/14/2022; 04/19/2022
• Supplement Dates FDA Received: 03/14/2022; 04/08/2022; 05/09/2022
• 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
• Treatment: ACETYLSALICYLIC ACID; AMLODIPINE; ATORVASTATIN; BETMIGA; HYDROCHLOROTHIAZIDE; METFORMIN; PANTOPRAZOLE