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

Catalog Number 05094798160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of erroneous results for 1 patient tested for elecsys troponin i stat immunoassay (troponin i stat) on a cobas e 411 immunoassay analyzer and a cobas 6000 e 601 module using the same reagent lot.The customer is not sure which result is correct.Erroneous results were reported outside of the laboratory.This medwatch will cover the e601 module serial number (b)(4) with reagent lot 18649500.Refer to medwatch with (b)(6) for information on the e411 analyzer with serial number (b)(4) also using reagent lot 18649500.There was no allegation that an adverse event occurred due to the device.The patient was sent to the other hospital for further testing.The patient had not had a heart attack.The customer continued to test each of the samples.The customer tested serum samples from the original sample obtained on (b)(6) 2017 at 1:55 p.M.And the result from the e601 module was 5.69 ng/ml.The result from the e411 analyzer was 1.81 ng/ml.The customer also sent the original sample to an external hospital laboratory that also uses roche instruments.The result from the e601 module was 4.46 ng/ml and repeated with a result of 4.49 ng/ml.The result from the e411 analyzer was 1.70 ng/ml and repeated with a result of 1.58 ng/ml.Neither of these results were reported outside of the laboratory.The sample was tested as a courtesy as part of troubleshooting.The field service engineer visited the customer site and did not make any changes to the instrument.Instrument tests were performed and all results passed.The customer performed precision testing and the results were acceptable.The customer also ran quality controls and the results were acceptable.The system is performing per specification.Serum and plasma samples for the patient were submitted for investigation.The samples were tested on an e601 module and an e411 analyzer used at the investigation site.During the investigation, the customer¿s results from the e601 module were reproduced on the e601 module at the investigation site.The customer¿s results from the e411 analyzer were reproduced on the e411 analyzer at the investigation site.The samples were also tested on an e601 using the troponin t high sensitive stat assay and all results were

Manufacturer Narrative

The customer submitted samples for investigation.The investigation reproduced the results obtained by the customer.Further investigation of the samples confirmed the presence of high molecular weight interferent comparable to igm.The interferent is most likely a human anti-mouse antibody (hama).This interferent is documented in product labeling.

• Brand Name: ELECSYS TROPONIN I STAT 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: 6604310
• MDR Text Key: 76422395
• Report Number: 1823260-2017-01118
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 05094798160
• Device Lot Number: 18649500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR