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

Catalog Number 03003523001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

The initial reporter questioned high results for 4 patient samples tested for chloride electrode (cl) on a cobas integra 400 plus.Discrepant results were provided for 1 patient sample.The initial result was 138 mmol/l.The sample was repeated 3 times with results of 119 mmol/l, 126 mmol/l, and 239 mmol/l.The customer did not know which result was correct.The results for this patient were not reported outside of the laboratory.

Manufacturer Narrative

The integra 400 plus serial number was (b)(6).The customer was also having qc issues.Calibration was last performed on (b)(6) 2023 with acceptable results.On the day of the event, qc was within the acceptable ranges at 7:28 a.M.The customer repeated qc multiple times between 1:00 p.M.And 2:00 p.M.And the results were outside of the acceptable ranges.The field service engineer (fse) found the issue was due to the cl electrode.The cl electrode was replaced.The fse confirmed all mechanisms were working properly and qc was acceptable.The maintenance actions (replacing the electrode) resolved the issue.

• Brand Name: CHLORIDE 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17376138
• MDR Text Key: 319585239
• Report Number: 1823260-2023-02412
• 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: Initial
• Report Date: 07/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Catalogue Number: 03003523001
• Device Lot Number: 21530147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• 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 Age: 58 YR
• Patient Sex: Female