MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E601
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys troponin t stat assay results from five patient samples tested on the cobas 6000 e601 module.The initial results were reported outside of the laboratory.The patient samples were rerun on their other e 601.The repeat results were reported to be less than the level of detection which is 0.010 ng/ml.On (b)(6) 2022: sample (b)(6)- the initial result from the module was 0.035 ng/ml.The repeat result was less than the level of detection of 0.010 ng/ml.On (b)(6) 2022: sample (b)(6)- the initial result from the module was 0.036 ng/ml.The repeat result was less than the level of detection of 0.010 ng/ml.Sample (b)(6)- the initial result from the module was 0.89 ng/ml.The repeat result was less than the level of detection of 0.010 ng/ml.On (b)(6) 2022: sample (b)(6)- the initial result from the module was 0.024 ng/ml.The repeat result was less than the level of detection of 0.010 ng/ml.On an unspecified date: sample (b)(6) - the initial result from the module was 1.8 ng/ml.The repeat result was less than the level of detection of 0.010 ng/ml.The repeat results were deemed correct.The reagent lot number and the expiration date were requested but not provided.
Additional Manufacturer Narrative
The field service engineer inspected the module and did not detect any problems.The fse performed mechanical and instrument checks with successful results.The customer stated that the black tanks have never been cleaned and that they have a lot of water problems with their water system.
Additional Manufacturer Narrative
The qc recovery was within the customer¿s established ranges on the date of the event.There was no indication of a performance issue with the reagent or instrument.The plasma samples were collected in lithium-heparinized small tubes.Rack adapters were not in use at the time of the event.Product labeling states "warning incorrect results when sample tubes are not aligned vertically incorrect placement of sample tubes in racks may cause incorrect sample pipetting, which may lead to false low results, especially when testing immunoassays.Ensure that sample tubes are always placed vertically in the racks.For sample tubes with an outer diameter of 13 mm or less, use the roche diagnostics cup adapter or use 13 mm mpa racks alternatively." the samples were centrifuged for 3 minutes and 10 minutes at 5000 and 3600 revolutions per minute (rpm) or relative centrifugal force (rcf).The centrifugation speed may be too high for both the 5000 and 3600 speeds per the tube manufacturer¿s recommended guidelines.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS E 601 MODULE
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15926317
• Report Number: 1823260-2022-03904
• Device Sequence Number: 5116100
• Product Code: JJE
• UDI-Device Identifier: 04015630921621
• UDI-Public: 04015630921621
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown