MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 ISE 1800 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05964075001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ise indirect k for gen.2 results from two patient samples tested on the cobas 8000 cobas ise module (double).The initial results were reported outside of the laboratory.The initial results were deemed questionable prompting the rerun of the patient samples on their other cobas 8000 ise module.Sample 1 the initial k result from the module with the patient sample in the primary tube was (b)(6).The repeat result from the other module with the patient sample in the primary tube was (b)(6).Sample 2 the initial k result from the module of the aliquoted patient sample was (b)(6).The repeat result from the other module of the aliquoted patient sample was (b)(6).The repeat results were deemed correct.
Additional Manufacturer Narrative
The electrode lot number and the expiration date were requested but not provided.The investigation reviewed the last calibration performed on 23-dec-2023; the results were within specifications.The investigation reviewed the qc recovery; the customer's target means and qc ranges were not provided.The customer stated that their qc recovery was acceptable before the event.The investigation reviewed the alarm trace; the trace contained "voltage level (ise 2)", "conditioning abnormal (ise 2)", and "calibration compensated limit (ise 2)" errors.The field service engineer (fse) inspected the module and found the internal standard bottle had a crack and was leaking.The customer replaced the bottle and ran a reagent prime.The customer performed qc with successful results.The fse performed precision testing with successful results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 8000 ISE 1800 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
• MDR Report Key: 18476438
• Report Number: 1823260-2024-00097
• Device Sequence Number: 6398456
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2024

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 Catalogue Number: 05964075001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2023
• Initial Report FDA Received Date: 01/09/2024
• 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 Age: 62 YR
• Patient Sex: Male