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

Model Number	E601
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys hcg stat (hcg stat) on a cobas 6000 e 601 module.The initial result was 1609 miu/ml.This result was reported outside of the laboratory where the physician requested repeat testing as the result did not correspond to the patient¿s clinical picture.The repeat result was 1.00 miu/ml with a data flag.This result was believed to be correct.The hcg stat reagent lot number was 62829300 with an expiration date of 31-oct-2023.
Additional Manufacturer Narrative
The customer was not having issues with calibration, qc, or any other tests.The field service engineer (fse) did not find a cause for the event.The fse performed a 21-cup precision test with pooled patient serum with acceptable results.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023 with acceptable results.No qc data was provided, however, the customer stated qc was acceptable.The customer used a centrifugation time of 2 minutes with a speed of 8000 revolutions per minute (rpm).Based on the type of sample tubes the customer uses, this centrifugation time may be too short and the speed may be too fast.Maintenance alarms were observed during a review of the alarm trace data.A general instrument or reagent issue was not identified.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: 16306693
• Report Number: 1823260-2023-00359
• Device Sequence Number: 20595261
• Product Code: JJE
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• 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): 04/10/2023

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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 04/10/2023
• 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 Age: 18 YR
• Patient Sex: Female