MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 06473245001

Device Problem Low Test Results (2458)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

The bun reagent lot number is 771886.The expiration date was requested but not provided.The ca2 reagent lot number is 744185.The expiration date was requested but not provided.The field service engineer (fse) inspected the module and replaced the rinse tubing.He performed mechanical checks.The customer performed calibrations, qcs, and precision checks.The investigation determined the event was due to insufficient service maintenance.The investigation determined the service action (retubing the cell rinse tube) resolved the issue.

Event Description

The initial reporter received questionable ureal urea/bun and ca2 calcium gen.2 results from four patient samples tested on the cobas 8000 c702 module.Bb181862 the initial bun result was 1.9 mmol/l.The repeat result was 8.2 mmol/l.Bb969351 the initial bun result was 0.9 mmol/l.The repeat result was 5.7 mmol/l.Bb969351 the initial bun result was 0.7 mmol/l.The repeat result was 4.5 mmol/l.Bb181921 the initial ca2 result was 1.38 mmol/l.The repeat result was 2.52 mmol/l.

• Brand Name: COBAS 8000 C 702 MODULE
• Type of Device: CLINICAL CHEMISTRY 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: 18818354
• MDR Text Key: 336682498
• Report Number: 1823260-2024-00623
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: EI
• PMA/PMN Number: K100853
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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
• Patient Sequence Number: 1