MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number 07682913001

Device Problems Contamination (1120); High Readings (2459); Low Readings (2460); Non Reproducible Results (4029)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

The estradiol reagent lot number and expiration date were requested, but not provided.The field service engineer decontaminated tubing and syringes.Syringe seals were replaced and a wash station was cleaned.Measuring cell preparation maintenance cycles were performed; these were ok and there were no errors.Mechanism checks were performed and all probes and movement of the analyzer were ok.The customer ran calibration and controls; all were ok.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with elecsys estradiol iii on a cobas 8000 e 801 module.The first sample initially resulted in an estradiol value of 190 pmol/l and it repeated as 130 pmol/l.The second sample initially resulted in an estradiol value of 179 pmol/l and it repeated as 102 pmol/l.

Manufacturer Narrative

Upon review of the alarm trace, there were multiple errors on 02-aug-2023 and 23-aug-2023 indicating that cleaning maintenance is recommended.The provided quality control data showed a strong fluctuation in control results for all assays.Control results were both outside of range high and low.The investigation determined the issue was resolved by the service actions.The issue is consistent with inadequate analyzer maintenance.

• Brand Name: COBAS 8000 E 801 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17740017
• MDR Text Key: 323326047
• Report Number: 1823260-2023-02972
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K060373
• 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
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07682913001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1