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

Catalog Number 03003523001

Device Problem High Test Results (2457)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

The initial reporter received a questionable result for one patient sample tested with the chloride electrode on a cobas integra 400 plus with serial number (b)(4).The initial results were not reported outside of the laboratory.The patient samples were sent out for reruns to another site that uses a cobas c303.On (b)(6) 2022, the patient samples had the following results: patient sample 1 - the initial result from the analyzer using the reported electrode lot was 135 mmol/l.The repeat result from the other site was 103 mmol/l.Patient sample 2 - the initial result from the analyzer using the reported electrode lot was 121 mmol/l.The first repeat result from the other site was 107 mmol/l.Because of the difference in the patient sample results, the customer changed the chloride electrode with a new electrode lot.The calibration was not within specifications so they reinstalled the previous electrode.On (b)(6) 2022, the ion-selective electrode (ise) check failed.The chloride electrode was again changed with a new electrode lot.The calibration was within specifications.Patient sample 2's second repeat result from the analyzer using the new electrode lot was 108 mmol/l.The third repeat result from the analyzer using the new electrode lot was 108.7 mmol/l.

Manufacturer Narrative

The investigation is ongong.

Manufacturer Narrative

In mfr report ref #1823260-2022-02869-00, b5 - describe event or problem's first line should have been: "the initial reporter received questionable results for two patient samples tested with the chloride electrode on a cobas integra 400 plus with serial number (b)(6)." instead of: "the initial reporter received a questionable result for one patient sample tested with the chloride electrode on a cobas integra 400 plus with serial number (b)(6).".

Manufacturer Narrative

The field service engineer (fse) checked the electrodes and the ion-selective electrode (ise) tower seals and did not find any issues.He checked the mix and dry values.The mix value was within range.He noted an issue with the dry value and made adjustments.The dry value was now within range.He replaced the ise tubes and the probes.After service, no further issues were reported by the customer. the investigation determined the service actions 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: 15447140
• MDR Text Key: 306414826
• Report Number: 1823260-2022-02869
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 08430215015353
• UDI-Public: 08430215015353
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03003523001
• Device Lot Number: 21520660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• 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