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

Model Number	C501
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer determined that a reagent nozzle tubing was deformed and a solid connection was not being made.This allowed water to drip past the connector.The tubing was removed and the end was re-flared.Air purges and mechanism checks were performed.The tube was seated properly and there was no water dripping from the connection.Calibration and controls were successful.Microalbumin control recovery was the same as it was on a second analyzer.
Event or Problem Description
The initial reporter stated they have been having ongoing issues with patient sample recovery for albt2 tina-quant albumin gen.2 on the cobas 6000 c (501) module.The field service engineer had been out twice to address the issue and all probes were changed on one of the visits.The customer stated the issue seemed to start after using a new lot of calibrator.Data was provided for 5 patient samples tested for microalbumin.The initial values were measured either on (b)(6) 2022 or(b)(6)2022 and were reported outside of the laboratory.The samples were repeated on (b)(6)2022.The customer did not know which values were correct.The customer stated that the first two samples were tested prior to the visits from the engineer.Samples 3-5 were tested after the visits from the engineer.The first sample initially resulted in a microalbumin value of < 12 mg/l with a data flag.The sample was repeated, resulting in a value of 22 mg/l.The second sample initially resulted in a microalbumin value of 106.3 mg/l.The sample was repeated, resulting in a value of 22.1 mg/l.The third sample initially resulted in a microalbumin value of < 12 mg/l with a data flag.The sample was repeated, resulting in a value of 38.9 mg/l.The fourth sample initially resulted in a microalbumin value of 15.9 mg/l.The sample was repeated, resulting in a value of 25.9 mg/l.The fifth sample initially resulted in a microalbumin value of 1181 mg/l.The sample was repeated twice, resulting in a value of 595.5 mg/l with a data flag and 802.8 mg/l.The microalbumin reagent lot number was 65268801, with an expiration date of 30-apr-2024.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2022 was ok and there were no alarms.One level of control was outside of range four times prior to receiving results that recovered within range prior to the event.The second level of control was acceptable prior to the event.The investigation determined the service actions 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: 15831281
• Report Number: 1823260-2022-03689
• Device Sequence Number: 17411225
• 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): 12/09/2022

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: 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: 11/03/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/20/2022
• Supplement Report FDA Received Date: 12/09/2022
• 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