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 04/02/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable ise indirect gen 2 results from the cobas 6000 c501 module serial number (b)(4).The initial sodium result was 124 mmol/l and the repeat result was 136 mmol/l.The questionable result was not reported outside of the laboratory.The customer repeated the samples as they were double-checking the results due to previous calibration issues.

Manufacturer Narrative

The field service engineer found the reference cartridge was damaged.He replaced the reference cartridge and ran precision testing that was within specifications.The investigation determined the issue was resolved by the service actions.

• 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: 16772933
• MDR Text Key: 313614796
• Report Number: 1823260-2023-01329
• 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: 04/19/2023

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: 04/03/2023
• Initial Date FDA Received: 04/19/2023
• 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
• Patient Sex: Male