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

Catalog Number	05964075001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Calibrate (2440); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ise indirect na, k, and ci for gen.2 results from one patient sample tested on the cobas 8000 cobas ise module (double).The reporter stated they also had ion-selective electrode (ise) voltage errors in the ise calibrations.The initial results from ise 1 were reported outside the laboratory.The anion gap calculation was questioned prompting the rerun of the patient sample on the module's ise 2.The initial na result from ise 1 was 160 mmol/l.The repeat result from ise 2 was 139 mmol/l.The initial k result from ise 1 was 5.7 mmol/l.The repeat result from ise 2 was 4.3 mmol/l.The initial cl from ise 1 result was 86 mmol/l.The repeat result from ise 2 was 102 mmol/l.The repeat results were deemed correct.
Additional Manufacturer Narrative
The electrode lot numbers and their expiration dates were requested but not provided.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the module and found the sipper nozzle had a clot.He then cleaned the nozzle using a cleaning wire.He also cleaned the dilution vessel which he found to be dirty and cleaned the vacuum nozzle as well.He also checked the gear pump head (gph) pressure.He determined the issue was resolved.The customer performed calibrations, qcs and compared patient results from their other line; the results were acceptable.The investigation reviewed the calibration data; there were no alarms on the 29-jan-2024 calibration but multiple alarms on the (b)(6) 2024 calibration.The investigation reviewed the qc data; the results were within specifications.There was no indication of a performance issue with the reagent.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 46250-0457
• MDR Report Key: 18731634
• Report Number: 1823260-2024-00478
• Device Sequence Number: 5525097
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/13/2024

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: 01/30/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 03/13/2024
• 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: 26 YR
• Patient Sex: Female