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

Catalog Number	08464537001
Medical Device Problem Code	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
Additional Manufacturer Narrative
The na and cl electrodes' lot numbers and expiration dates were not provided.The customer had been experiencing qc issues with na since (b)(6) 2024 and stated that they had issues with failing qc recovery on the day of the event.The provided recovery was outside of the customer's provided upper limits na and cl and had qc error alarms.The calibration was last performed on (b)(6) 2024 and it was acceptable with no noted alarms.Ises were recalibrated at 9:59 am and they were successful with no alarms.Pre-analytical data was provided and it showed that the spin time might be shorter than recommended and the spin speed might be faster than recommended.The alarm trace showed multiple alarms including sample probe abnormal aspiration alarms, sample clot detection alarms, abnormal aspiration (sample pipetter s1) alarms, and sample foam detection alarms.These are indicators of possible poor sample quality.The field service engineer (fse) found that the vacuum nozzle was worn out causing the liquid mix to be left behind in the dilution vessel.He replaced the vacuum nozzle and cleaned the sample probe wash station.He also cleaned the dilution vessel and performed reagent primes.The fse verified the instrument by performing calibration and qc and they were successful.The service actions (replacing the vacuum nozzle, and cleaning the sample probe wash station and the dilution vessel) resolved the issue.No further issues were reported afterward.
Event or Problem Description
We received an allegation of questionable ise results for 3 patients' urine samples tested on a cobas pro ise analytical unit when compared to a different cobas pro ise analytical unit.Results for the following tests were affected: sodium (na) and chloride (cl).Sample 1: na: initial result: 151 mmol/l.Repeat result: 139 mmol/l (tested on another cobas pro ise).Sample 2: na: initial result: 150 mmol/l.Repeat result: 139 mmol/l (tested on another cobas pro ise).Sample 3: na: initial result: 151 mmol/l.Repeat result: 139 mmol/l (tested on another cobas pro ise).Cl: initial result: 114 mmol/l.Repeat result: 103 mmol/l (tested on another cobas pro ise).Delta checks on patient samples prompted the repeat of the samples.The repeat results were deemed to be 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: 18730658
• Report Number: 1823260-2024-00475
• Device Sequence Number: 7255509
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 02/19/2024

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: 01/29/2024
• Initial Report FDA Received Date: 02/19/2024
• 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