MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 701 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05641489001
Medical Device Problem Codes	Application Program Problem (2880); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c701 module serial number was (b)(6).
Event or Problem Description
The initial reporter alleged the cobas 8000 c 701 module provided results for an unspecified number of patient urine samples tested for albumin gen.2 (albt2) when the reagent cassette was empty.After loading the reagent cassette the customer reportedly repeated patient samples.The results for 1 patient sample were discrepant.The customer alleges a result of 47 mg/l was received while the reagent cassette was empty.The repeat result was 103 mg/l.
Additional Manufacturer Narrative
Section b3 was updated.The initial report stated: "the c701 module serial number was (b)(6)." the c701 module serial number was (b)(6).The initial report stated: "the customer alleges a result of 47 mg/l was received while the reagent cassette was empty.The repeat result was 103 mg/l." the repeat result was from a different c701 module.Discrepant results were provided for an additional patient sample (patient 2): patient 2 result from the c701 module in question was 7 mg/l.The result from a different c701 module was 24 mg/l.
Additional Manufacturer Narrative
The albt2 reagent lot number was 714994.The expiration date was not provided.Calibration was acceptable.Qc data shows some high results.Frequent "sample short" alarms were observed on the alarm trace data.All of the questionable results were obtained with reagent lot 714994.One qc result was generated after the patient results.It could not be confirmed that these results were obtained using an empty reagent cassette.The field service engineer (fse) found an issue with the gear pump and replaced the gear pump head.The investigation determined the issue identified by the fse was the cause of the event.

• Brand Name: COBAS 8000 C 701 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 46250-0457
• MDR Report Key: 18359240
• Report Number: 1823260-2023-04121
• Device Sequence Number: 20429004
• Product Code: JJE
• UDI-Device Identifier: 04015630928255
• UDI-Public: 04015630928255
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2024
• 2 Devices were Involved in the Event: 1 2

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: 05641489001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 01/23/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/16/2024; 01/23/2024
• 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