MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 2 patient urine samples tested for albt2 tina-quant albumin gen.2 (albt2) on a cobas 6000 c (501) module.Patient 1 initial result was 63.3 mg/l.This result was not consistent with other results for the sample so the laboratory repeated the sample on a different analyzer (method unknown) and the result was "normal." on (b)(6) 2022 the sample was repeated twice on the c501 module with results of 0.3 mg/l with a data flag.Another result from the sample was provided of 20.4 mg/l.This result was reported outside of the laboratory.Patient 2 initial result was 23 mg/l.The sample was repeated twice with results of 14 mg/l and 22 mg/l.It is not clear which results are believed to be correct.The albt2 reagent lot number is 59240101 with an expiration date of 30-sep-2023.
Additional Manufacturer Narrative
The field service engineer (fse) did not find a cause for the issue.Frequent calibration alarms were observed.Qc shows imprecision with extremely high results.No issues were identified on the alarm trace data.The investigation is ongoing.
Additional Manufacturer Narrative
Discrepant results were provided for an additional patient urine sample (patient 3): on (b)(6) 2022 the initial albt2 result was 31 mg/l.The repeat result was 3 mg/l.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) replaced the gear pump head on (b)(6) 2022.On (b)(6) 2022 discrepant results were provided for an additional patient urine sample (patient 4): the initial albt2 result was 64.5 mg/l.The sample was repeated twice with results of 1.6 mg/l with a data flag and 1.8 mg/l with a data flag.The repeat results were believed to be correct.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) found that the valve of the main water tank had been closed by accident and remained closed during the routine operation of the instrument.This caused damage to the water pump which caused the sample probes to not be cleaned sufficiently causing the high albt2 results.The customer may not have opened the valve after cleaning the black water tank after monthly operator maintenance.The issue was resolved by replacing the main water pump and opening the closed valve.The customer has not complained of any further issues.

• Brand Name: COBAS 6000 C501 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: 15914798
• Report Number: 1823260-2022-03850
• Device Sequence Number: 4348017
• Product Code: JJE
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/01/2023

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: C501
• Device Catalogue Number: 04745914001
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 12/09/2022; 12/30/2022; 01/26/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/22/2022; 01/13/2023; 02/01/2023
• 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 Age: 42 YR
• Patient Sex: Male