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	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number is p77.The \expiration date was requested but not provided.The field service engineer (fse) inspected the analyzer and found a defective ion-selective electrode (ise) standard valve.He then replaced this valve.The customer performed calibrations, qcs, a 21-cup precision check, and a patient cross-check with acceptable results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter received questionable ise indirect na for gen.2 results from four patient samples tested on the cobas pro ise analytical unit.The initial results were reported outside of the laboratory.Sample 1 the initial na result was 149 mmol/l.The doctor questioned the result prompting the rerun of the patient sample.The repeat result was 137 mmol/l.Sample 2 the initial na result was 150 mmol/l.The doctor questioned the result prompting the rerun of the patient sample.The repeat result was 140 mmol/l.Sample 3 the initial na result was 149 mmol/l.The result failed a delta check prompting the rerun of the patient sample.The repeat result was 139 mmol/l.Sample 4 the initial na result was 151 mmol/l.The result failed a delta check prompting the rerun of the patient sample.The repeat result was 140 mmol/l.The repeat results were deemed correct.

• 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: 18551006
• Report Number: 1823260-2024-00188
• Device Sequence Number: 12661711
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2024

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): Initial
• Initial Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 01/22/2024
• 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