MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 05860636001

Device Problem Low Test Results (2458)

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

Event Date 03/18/2024

Event Type  malfunction  

Event Description

The initial reporter received a questionable ise indirect ci for gen.2 result from one patient sample tested on the cobas 6000 c 501 (ul) v.The initial result was not reported outside of the laboratory.The patient sample was rerun because the low initial na result was deemed critical.The initial cl result from the module was 120.1 mmol/l.The repeat result from another c 501 module was 102 mmol/l.The repeat result was deemed correct.

Manufacturer Narrative

The electrode lot number is n16.The expiration date was requested but not provided.The investigation reviewed the last calibration performed on 18-mar-2024; the results were within specifications.The investigation reviewed the qc recovery; the results were within specifications before the event.The investigation reviewed the alarm trace; no issues were noted.The field service engineer inspected the module and found that the event was caused by environmental surface tension within a slot of the ion-selective electrode (ise) bath.He then went through the entire ise flow path, cleaned, lubricated the lever, and decontaminated the reference bottle tubing.He performed ise checks (30 times) and calibrations with acceptable results.The customer performed qc with acceptable results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 6000 C (501) 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: 19036619
• MDR Text Key: 339293818
• Report Number: 1823260-2024-01027
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/03/2024
• 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
• Patient Age: 23 YR
• Patient Sex: Female