MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (DISK SYSTEM); IMMUNOCHEMISTRY ANALYZER

Model Number	E411 DISK
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys hcg stat on a cobas e 411 analyzer (disk system).The sample initially resulted in a value of 1.71 iu/l and repeated as 197.9 iu/l.On (b)(6) 2022, the sample was repeated resulting in a value of 207.3 iu/l.The initial questionable result was reported outside of the laboratory.The reagent lot was 566669 with an expiration date of 31-jan-2023.
Additional Manufacturer Narrative
The customer used 13 mm tubes without rack adapters.The number of tube inversions appeared to be lower compared to the tube manufacturer¿s instructions.The sample centrifugation time may have been shorter than recommended by the tube manufacturer and the speed may have been inadequate.According to the information provided, the calibration and quality control results were acceptable.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS E 411 ANALYZER (DISK SYSTEM)
• 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: 15782558
• Report Number: 1823260-2022-03593
• Device Sequence Number: 14670895
• Product Code: JJE
• UDI-Device Identifier: 04015630919383
• UDI-Public: 04015630919383
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: E411 DISK
• Device Catalogue Number: 4775279001
• 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: 10/18/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 12/29/2022
• 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: 37 YR
• Patient Sex: Female