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

Catalog Number 08464537001

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

Upon inspection of the ise dilution cup, some serum residue was determined at the sipper needle.The needle was replaced and the vessel was cleaned.The field service engineer checked the instrument and found worn syringe seals.He replaced the syringe seals and replaced the vacuum tubing and the vacuum nozzle.After service, no further issues were reported by the customer.  the investigation determined the service actions resolved the issue.

Event Description

The initial reporter stated they received discrepant ise results for multiple patient samples tested on a cobas pro ise analytical unit.A total of 70 test results were corrected.The following examples of discrepant results for 5 patients tested for sodium (na) were provided.Patient 1 had an initial na value of 139 mmol/l.The sample was repeated resulting in a value of 7 mmol/l.Patient 2 had an initial na value of 132 mmol/l.The sample was repeated resulting in a value of 10 mmol/l.Patient 3 had an initial na value of 138.5 mmol/l.The sample was repeated resulting in a value of 9.5 mmol/l.Patient 4 had an initial na value of 141.9 mmol/l.The sample was repeated resulting in a value of 7.1 mmol/l.Patient 5 had an initial na value of 140.8 mmol/l.The sample was repeated resulting in a value of 7.2 mmol/l.The questionable results were reported outside of the laboratory.The na electrode lot number and expiration date were requested but not provided.

• Brand Name: COBAS PRO ISE ANALYTICAL UNIT
• Type of Device: 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15968352
• MDR Text Key: 308179059
• Report Number: 1823260-2022-03984
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K191899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08464537001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1