MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C502
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 17-sep-2022 calibration was within specifications.The customer's qc recovery was provided but the target means and ranges were not provided.The customer stated that their qc recovery was acceptable.The patient sample was centrifuged for 5 minutes at 3500 rpm.The customer's centrifugation time may be shorter than recommended.The field service engineer (fse) inspected the module and found that the sodium hydroxide detergent (naoh-d) nozzle was not moving freely.He then cleaned and checked the naoh-d nozzle.He also found that the sample probe was not springing down and was stuck in its upper position.He then performed an air purge.He found that the water stream was going sideways.He then changed and adjusted the sample probe.He also checked the rinsing and adjusted the gear pump pressure.He verified the module's performance with a 10-cup precision test 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. .
Event or Problem Description
The initial reporter received a questionable iga-2 tina-quant iga gen.2 result for one patient sample tested on the cobas 8000 cobas c 502 module.The initial result was reported outside of the laboratory.The result was different from the previous result of the patient from 4 days prior.The initial result was 71 mg/dl.The first repeat result was 0 mg/dl with a data flag.The second repeat result was 3 mg/dl with a data flag.The third repeat result was 0 mg/dl with a data flag.The fourth repeat result was 2 mg/dl with a data flag.The reporter released a result of <5 mg/dl.The repeat result was deemed correct.The reagent lot number is 58129801 with an expiration date of 31-aug-2023.

• Brand Name: COBAS 8000 C 502 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15608084
• Report Number: 1823260-2022-03165
• Device Sequence Number: 11280696
• Product Code: JJE
• UDI-Device Identifier: 04015630919680
• UDI-Public: 04015630919680
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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 Model Number: C502
• Device Catalogue Number: 05964067001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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