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

Model Number	C501
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for 5 patient urine samples tested with albt2 (tina-quant albumin gen.2) on a cobas 6000 c (501) module.Patient 1: the sample initially resulted in a value of 18.26 mg/dl.The initial result was reported outside of the laboratory.The physician questioned the result together with two additional albt2 patient results obtained on the same day.The sample from patient 1 was repeated on a second analyzer resulting in a value of 13.68 mg/dl.The customer then repeated 20 samples from the same day and noted discrepant albt2 results for 4 additional patient samples.Patient 2: the sample initially resulted in a value of 18.66 mg/dl.The sample was repeated on a second analyzer resulting in a value of 1.29 mg/dl.Patient 3: the sample initially resulted in a value of 31.57 mg/dl.The sample was repeated on a second analyzer resulting in a value of 0.63 mg/dl.Patient 4: the sample initially resulted in a value of 4.08 mg/dl.The sample was repeated on a second analyzer resulting in a value of <0.40 mg/dl accompanied by a data flag.Patient 5: the sample initially resulted in a value of 18.18 mg/dl.The sample was repeated on a second analyzer resulting in a value of <0.40 mg/dl accompanied by a data flag.The repeat results were deemed correct.The questionable results were reported outside of the laboratory.The albt2 reagent lot number was 61716201, with an expiration date of 31-dec-2023.
Additional Manufacturer Narrative
The last calibration was performed on 07-oct-2022 and was acceptable with no alarms.Quality control data was not provided.Upon review of the alarm trace, several "abnormal probe sucking" errors were observed.These are indicators of possible poor sample quality.The field service engineer found a misadjusted sample probe.After adjustment of the sample probe, the issue was solved.The investigation determined the service actions performed resolved the issue.

• Brand Name: COBAS 6000 C (501) 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: 15754758
• Report Number: 1823260-2022-03552
• Device Sequence Number: 14192756
• Product Code: JJE
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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): 01/05/2023

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: 05860636001
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/05/2023
• 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: 52 YR
• Patient Sex: Male