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

Catalog Number	06473245001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 71725901 with an expiration date of 30-jun-2024.The customer's calibration results were ok.There was no indication of a reagent issue.The investigation reviewed the system's alarm trace and numerous abnormal aspiration errors were observed.These are indicators of possible poor sample quality.The field service representative found the instrument to be contaminated.He cleaned the black water tanks, cleaned and decontaminated the instrument, performed a bath exchange, and discussed cleaning the water tanks with the customer.He verified the instrument by performing cell blank and photometer checks and having the customer perform calibration and qc successfully.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable ca2 results for multiple patient samples on a cobas 8000 c 702 module.One example was provided.The initial result was 6.684 mg/dl.The repeated results were 8.972 mg/dl and 9.0 mg/dl.The result of 9.0 mg/dl was believed to be correct.The samples were repeated due to the customer noticing a large number of low results and samp.C flags.

• Brand Name: COBAS 8000 C 702 MODULE
• Common Device Name: 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: 18743267
• Report Number: 1823260-2024-00495
• Device Sequence Number: 6509551
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown