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

Catalog Number	05860636001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na and k results for 1 patient sample on a cobas 6000 c (501) module.This medwatch will cover k.Refer to medwatch with a1 patient identifier pt (b)(6) for information on the na results.The initial na result was 126 mmol/l and the initial k result was 4.66 mmol/l.The customer questioned the low results and was prompted to repeat the sample.The sample was repeated on another (b)(6) analyzer and the repeat na result was 138 mmol/l and the repeat k result was 4.21 mmol/l.The repeat results were deemed correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The qc recovery data provided was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Section d product information has been updated, as well as g1 manufacturing site and g4.Na and k calibration was last performed on 24-feb-2024 and was acceptable.The qc recovery data provided was acceptable.There was no indication of a reagent performance issue.The alarm trace showed multiple ise noise, ise internal reference, and calibration alarms on the day of the event.The field service engineer (fse) cleaned the electrode compartment, primed the analyzer, lubricated latching mechanism, and performed ise checks, calibration, and qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18960455
• Report Number: 1823260-2024-00872
• Device Sequence Number: 17867532
• Product Code: JJE
• UDI-Device Identifier: 04015630037681
• UDI-Public: 04015630037681
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 04/18/2024
• 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: 05860636001
• Device Lot Number: B6702
• 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: 02/25/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/18/2024
• 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 Age: 51 YR
• Patient Sex: Female