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

Catalog Number 05860636001

Device Problem Low Test Results (2458)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  Injury  

Event Description

The initial reporter received questionable ise indirect na for gen.2 results from multiple patient samples tested on the cobas 6000 c501 (ul) v.The reporter stated the questionable results from (b)(6) 2024 had to be corrected.Please refer to the attachment (b)(4) for the table containing the examples of questionable na results.

Manufacturer Narrative

The electrode lot number and the expiration date were requested but not provided.The field service engineer (fse) inspected the analyzer and determined the event was caused by a leak in the connection of solenoid valve (sv) 28 from the reference bottle.He then inspected the error trace and did not find indicators of any issues.He inspected and cleaned the ion-selective electrode (ise) reference bottle filter and performed an initial precision test with poor results.He cleaned the valve, reformed the connection, and reinstalled the valve.He verified the module's performance with ise primes, repeat precision tests, and recalibrations with acceptable results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

Manufacturer Narrative

On 24-apr-2024, the customer provided additional questionable ise indirect na and k for gen.2 results and medical information for the patients whose samples were tested on the reported cobas 6000 c (501) module.It was alleged that patients were admitted to the hospital based on the low sodium results.There was no report of any other alleged harm or injury.Medwatch fields b1 and b2 were updated out of an abundance of caution.Please refer to the attachment pt-0067940 in the medwatch for the highlighted additional questionable results and additional medical information provided.

• 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: 19031260
• MDR Text Key: 339223755
• Report Number: 1823260-2024-01016
• 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,Followup
• Report Date: 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/21/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/24/2024
• 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
• Treatment: 0319:C02615 - HYDROCHLOROTHIAZIDE; 0319:C02615 - LOSARTAN
• Patient Outcome(s): Required Intervention; Other; Hospitalization