MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS PRO ISE ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	08464537001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode lot numbers and their expiration dates were requested but not provided.The field service engineer (fse) inspected the analyzer and changed the gaskets from the vacuum pump and the vacuum nozzle from the ion-selective electrode (ise) mode.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable ise indirect na and k for gen.2 results from one patient sample tested on the cobas pro ise analytical unit.The initial na result was 163.3 mmol/l.The first repeat result was 149.1 mmol/l.The second repeat result was 151.6 mmol/l.This result was reported to the patient.The initial k result was 4.89 mmol/l.The repeat result was 4.43 mmol/l.
Additional Manufacturer Narrative
On the field service engineer's (fse) follow-up visit, he found that the daily maintenance stopped due to insufficient volume error of the ion-selective electrode (ise) internal standard (is).He then primed the reagent flow path, incubation water exchange, and performed an air purge which resolved the issue.He also changed the electrodes, cleaned the ultrasonic washing station and performed 30 cycles of ise check 30 and precision ise checks.The investigation determined the event was caused by a leakage/seal.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS PRO ISE ANALYTICAL UNIT
• 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: 18650327
• Report Number: 1823260-2024-00338
• Device Sequence Number: 8200895
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• PMA/510(K) Number: K191899
• 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
• Report Date (Section B): 03/08/2024

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: 08464537001
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/08/2024
• 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