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

Catalog Number 09237216001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The c501 analyzer serial number is (b)(6).The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the ise sodium electrode on a cobas 6000 c (501) module.No questionable results were reported outside of the laboratory.The sample initially resulted in a na value of 164 mmol/l with a data flag.The customer repeated the sample since samples with any critical values are to be repeated.The sample was repeated, resulting in a value of 139 mmol/l.The repeat value was deemed correct and matched the patient's history.

Manufacturer Narrative

The last calibration performed on (b)(6) 2024 was acceptable.The customer indicated that controls were within range at the time of the event.The sample centrifugation speed may have been lower than recommended by the tube manufacturer.Upon review of the alarm trace, an incubator bath water level sensor alarm, a fuse failure alarm, and a voltage alarm were observed.A sample short alarm and abnormal probe aspiration alarm were also observed; these are indicators of poor sample quality.The field service engineer found dried detergent buildup on the reaction cells of the analyzer.Moisture was also found on top of reaction cells.The buildup was intermittently affecting the water supply valve to the detergent mixer.The valve could occasionally be stuck open, causing an overflow of detergent.The water supply valve bank was replaced.Mechanism checks were successful.Calibration, controls, and precision studies were acceptable.The investigation determined the service actions resolved the issue.

• Brand Name: ISE SODIUM ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, SODIUM
• 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 46250-0457
• MDR Report Key: 18857020
• MDR Text Key: 337189817
• Report Number: 1823260-2024-00694
• Device Sequence Number: 1
• Product Code: JGS
• 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,Followup
• Report Date: 03/27/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09237216001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN (TYLENOL); BIOTIN.; BUPROPION (WELLBUTRIN SR).; DAPAGLIFLOZIN (FARXIGA).; DOFETILIDE (TIKOSYN).; FUROSEMIDE.; GABAPENTIN (NEURONTIN).; IRON.; LACTULOSE ORAL SOLUTION.; METFORMIN (GLUCOPHAGE XR).; PRAVASTATIN (PRAVACHOL).; RIFASIMIN (XIFAXAN).; SEMAGLUTIDE (OZEMPIC).; SENNA (SENOKOT).; SPIRONOLACTONE (ALDACTONE).; TRESIBA FLEXTOUCH PEN.; VITAMIN B COMPLEX.
• Patient Age: 74 YR
• Patient Sex: Female