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

Catalog Number	06473245001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable astlp aspartate aminotransferase acc.To ifcc with pyridoxal phosphate activation and altl alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation results for 3 patient samples on a cobas 8000 c702 module.The customer noticed data flags on multiple results which prompted them to repeat patient samples.For patient 1, the initial alt result was 44 u/l and the initial ast result was 21 u/l.The sample was repeated on another c702 analyzer and the repeat alt result was 15 u/l and the repeat ast result was 17 u/l.For patient 2, the initial alt result was 35 u/l and the initial ast result was 42 u/l.The sample was repeated on another c702 analyzer and the repeat alt result was 14 u/l and the repeat ast result was 22 u/l.For patient 3, the initial alt result was 51 u/l and the initial ast result was 40 u/l.The sample was repeated on another c702 analyzer and the repeat alt result was 11 u/l and the repeat ast result was 17 u/l.The repeat results were deemed correct.
Additional Manufacturer Narrative
The ast reagent lot number is 746282.The alt reagent lot number is 730435.The expiration dates were not provided.The qc recovery data provided prior to the event was acceptable.The field service engineer (fse) replaced a solenoid valve, the incubator bath liquid level detector sensor, the heat cut filter, and the photometer lamp.The fse adjusted the rinse and cell blank levels, performed mechanism checks and photometer checks, and performed a precision test successfully.The customer performed qc and calibration successfully.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on 14-jan-2024.The alarm trace showed multiple calibration errors and sample short alarms on the date of the event around the time the affected sample was processed.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 18695857
• Report Number: 1823260-2024-00417
• Device Sequence Number: 12845053
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 03/01/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/01/2024
• 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