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

Catalog Number 21039415001

Device Problem High Test Results (2457)

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

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable high ise indirect gen results from the cobas pro ise analytical unit that were reported outside of the laboratory and were later corrected.Only data for one sample that was not reported outside of the laboratory was provided.The initial sodium result was 146 mmol/l.As the qc results were high, the sample was repeated on another analyzer and the result was 138 mmol/l, which was believed to be correct.The electrode lot number and expiration date were requested but were not provided.

Manufacturer Narrative

The field service representative found there was an issue with the chloride electrode.He checked the ise flow path, calibration, and qc.He replaced the chloride electrode.Repeated ise calibration and qc with results within range.Sodium calibration was ok, with no alarms.Upon review of control data, sodium controls were outside of range on (b)(6) 2022 and (b)(6) 2022.Multiple sample probe aspiration alarms occurred on the day of the event.The investigation determined the service actions resolved the issue.Medwatch fields d1-d4, g1, and g4 were updated.

• 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: 14603803
• MDR Text Key: 302058589
• Report Number: 1823260-2022-01631
• Device Sequence Number: 1
• Product Code: CGZ
• 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,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21039415001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• 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: 3 DA
• Patient Sex: Male