MAUDE Adverse Event Report: ROCHE DIAGNOSTICS REFERENCE ELECTRODE

Catalog Number 03149501001

Device Problem Low Test Results (2458)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

The electrode lot number and the expiration date were requested but not provided.The field service engineer inspected the module and found that the reference electrode was not working as expected.He then replaced this part.The customer performed calibrations and qc with successful results.The installation date of the previous reference electrode was requested but not provided.Product labeling states "every 6 months maintenance of the ise module perform these maintenance actions at least every 6 months.In this section - replacing the reference electrode of the ise module: to ensure the measurement accuracy of the ise unit, you must replace the reference electrode." the investigation noted that multiple calibrations were performed on (b)(6) 2023 and the results were acceptable.The calibration performed on (b)(6) 2023 showed multiple errors.The investigation noted that the qc recovery was low but not out of range.On 19-jun-2023 unit 20-jun-2023, the qc recovery for level 1 was -2 standard deviations (sd); on 19-jun-2023, the qc recovery for level 2 was -2 sd and on 20-jun-2023, the qc recovery for level 2 was initially at -2 sd; the subsequent measurements were higher and above the mean.The investigation noted that the customer centrifuges the patient samples for 3 minutes at 13,000 rpm if they are stat samples; or 10 minutes at 4000 rpm if they are centrifuged in the 8100.The centrifugation time for stat samples may be shorter than recommended and the centrifugation speed may be much faster than recommended.The investigation noted that the alarm trace contained "abnormal aspiration (sample probe)", "abnormal aspiration (sample probe a/b)", "abnormal sample aspiration", "sample clot detection", "sample foam detection", and "sample short" errors.These are indicators of possible poor sample quality. after service, no further issues were reported by the customer.  the investigation determined the service actions resolved the issue. .

Event Description

The initial reporter received questionable ise indirect na for gen.2 results from 30 patient samples tested on the cobas 8000 cobas ise module (double).The initial results were reported outside of the laboratory.The reporter stated they have been receiving low na patient results.They changed the electrodes a day before the date of the event; and then by late afternoon, they started noticing their moving averages for na were running lower in the ion-selective electrode 1 (ise 1) of the module than in their other 5 modules.They then reran the qc and the results were noted to be out of range - low.They recalibrated the assay and the qc was within range after recalibration.They then resumed operations.They once again noted that their moving averages for na were starting to drop and qc was noted to have dropped out again as well, prompting the rerun of patient samples on their other cobas 8000 ise module.The reporter was able to provide two examples of discrepant results.Patient 1: the initial na result from the module was 133 mmol/l.The repeat result from the other module was 138.8 mmol/l.Patient 2: the initial na result from the module was 146 mmol/l.The repeat result from the other module was 151.9 mmol/l.The repeat results were deemed correct.

• Brand Name: REFERENCE ELECTRODE
• Type of Device: REFERENCE ELECTRODE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17325878
• MDR Text Key: 319676681
• Report Number: 1823260-2023-02253
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 03149501001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/14/2023
• 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