MAUDE Adverse Event Report: ROCHE DIAGNOSTICS NA ELECTRODE; ELECTRODE, ION SPECIFIC, SODIUM

Catalog Number 10825468001

Device Problem High Test Results (2457)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

The initial reporter received a questionable ise indirect na for gen.2 result from one patient sample tested on the cobas pro ise analytical unit.The initial result was reported outside of the laboratory.The reporter stated the patient had two separate samples (sample 1 and sample 2) and both samples had ion-selective electrode (ise) orders.The physician questioned the difference in the results prompting the rerun of the patient sample.Sample 1 on (b)(6) 2024: the initial na result from the module was 155 mmol/l.On (b)(6) 2024: the repeat result from the other module was 146 mmol/l.The repeat result was deemed correct.Sample 2 on (b)(6) 2024: the initial na result from the other module was 146 mmol/l.On (b)(6) 2024: the repeat result from the module was 145 mmol/l.

Manufacturer Narrative

The serial number of the cobas pro ise analytical unit is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The field service engineer (fse) inspected the analyzer and could not determine the cause of the event.He replaced the sipper and vacuum nozzles.He performed ion-selective electrode checks with no errors the investigation reviewed the last calibration performed on 21-feb-2024 (date of event); no alarms were noted.Calibration alarms were noted in calibrations before the event.The investigation reviewed the qc recovery; the qc recovery was within -2 standard deviations and acceptable.There was no indication of a performance issue with the reagent.The investigation reviewed the alarm trace; sample (short, foam and clot), qc, volume decrease, abnormal liquid level, and incomplete calibration alarms were noted.After service, no further issues were reported by the customer.The cause of the event could not be determined.

• Brand Name: NA ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, SODIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18913101
• MDR Text Key: 337769374
• Report Number: 1823260-2024-00769
• Device Sequence Number: 1
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (y/n): Y
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10825468001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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