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

Catalog Number	08464537001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na and k electrode lot numbers and expiration dates were not provided.The qc recovery data provided was acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na and k results for 12 patient samples on a cobas pro ise analytical unit.The patients' doctor questioned the results which prompted the customer to repeat the patient samples.For sample 1, the initial na result was 130.0 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 138.3 mmol/l.For sample 2, the initial na result was 126.5 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 133.5 mmol/l.For sample 3, the initial na result was 128.9 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 137.1 mmol/l.For sample 4, the initial na result was 127.4 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 135.4 mmol/l.For sample 5, the initial na result was 129.2 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 137.4 mmol/l.For sample 6, the initial na result was 128.9 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 137.6 mmol/l.For sample 7, the initial na result was 125.4 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 133.6 mmol/l.For sample 8, the initial na result was 127.2 mmol/l and the initial k result was 3.63 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat na result was 135.4 mmol/l and the repeat k result was 4.07 mmol/l.For sample 9, the initial na result was 119.9 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 127.2 mmol/l.For sample 10, the initial na result was 127.7 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 136.0 mmol/l.For sample 11, the initial na result was 129.4 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 138.4 mmol/l.For sample 12, the initial na result was 128.6 mmol/l.The sample was repeated the next day on another cobas pro analyzer and the repeat result was 137.2 mmol/l.
Additional Manufacturer Narrative
The investigation noted that there were multiple qc expired, out-of-range, and sample aspiration alarms surrounding the event.Aspiration alarms can be an indication of poor sample quality.The field service engineer (fse) inspected the analyzer and determined that the event was caused by worn ion-selective electrode (ise) pinch valve tubing and sipper tubing.He then inspected all assemblies.Cleaned the wash bath, sample probe, and ise sipper.Replaced the pinch valve tubing and sipper tubing, changed all of the syringe seals, and verified the alignment.He performed an air purge, reagent prime, ise checks (x50), and mechanical checks with successful results.Calibrations, qcs.Crosschecks with another module were performed 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 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: 18789863
• Report Number: 1823260-2024-00560
• Device Sequence Number: 15407348
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• 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,Followup
• Report Date (Section B): 03/21/2024

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: 02/02/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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