MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CL- ELECTRODE; ELECTRODE, ION-SPECIFIC, CHLORIDE

Model Number I400+

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 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

The customer replaced the chloride electrode but noticed multiple bubbles in the electrode.The field service engineer was unable to determine a cause.He checked the mix/dry settings and pinch valves and performed calibrations that failed.He replaced the new chloride electrode with the customer's original electrode.Calibration, qc, and precision testing then passed.The investigation is ongoing.

Event Description

There was an allegation of questionable ise indirect gen.2 results from the cobas integra 400+ analyzer.Patient sample 1 initial sodium result was 151 mmol/l.The patient was sent to the er for a new sample to be drawn and the result was 144 mmol/l.The original sample was repeated on a cobas 6000 analyzer and the result was 143 mmol/l.Patient 2 initial sodium result was 149 mmol/l and the repeat result was 140 mmol/l.Patient 3 initial sodium result was 148 mmol/l and the repeat result was 140 mmol/l.The questionable results were reported outside of the laboratory.The repeat results were believed to be correct.The electrode lot number and the expiration date were requested but were not provided.

Manufacturer Narrative

The investigation determined the service actions of replacement of the chloride electrode resolved the issue.

• Brand Name: CL- ELECTRODE
• Type of Device: ELECTRODE, ION-SPECIFIC, CHLORIDE
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13769162
• MDR Text Key: 294257795
• Report Number: 1823260-2022-00700
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 08430215015353
• UDI-Public: 08430215015353
• 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: Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: I400+
• Device Catalogue Number: 03003523001
• Device Lot Number: 21514147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• 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 Age: 57 YR
• Patient Sex: Male