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

Catalog Number ASKU

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable gen.2 ise indirect for na and cl results for 1 patient sample on a cobas 6000 c (501) module.This medwatch will cover cl.Refer to medwatch with a1 patient identifier (b)(6) for information on the na results.The initial cl result was 141 mmol/l.The customer questioned the results as they were accompanied by a negative anion gap and repeated the sample.The sample was repeated on another c501 analyzer and the repeat cl result was 104 mmol/l.The repeat results were deemed correct.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

The analyzer serial number is (b)(6).It was found that the customer centrifuges their patient samples for 7 minutes, at 4200 rpm, which may be too short.The qc recovery data provided was acceptable.The investigation is ongoing.

Manufacturer Narrative

The field service egnineer (fse) performed ise checks and a patient pool precision test successfully and checked probe alignments and rinse volumes.The customer performed qc successfully.The alarm trace did not contain a conspicuous event.A product problem was not identified.The root cause of the event could not be determined.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18048125
• MDR Text Key: 327078237
• Report Number: 1823260-2023-03486
• Device Sequence Number: 1
• Product Code: CGZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: ASKU
• 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: 12/18/2023

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female