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

Catalog Number 03246353001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas 4000 c (311) stand alone system is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable ise indirect na and ci for gen.2 results from an unspecified number of patient samples tested on the cobas 6000 c 501 (ul) v and the cobas 4000 c311 stand alone system.This mdr is for the cl assay processed in the cobas 4000 c311 stand alone system.Please refer to medwatch with a1.Patient identifier (b)(6) for the report on the na assay processed in the cobas 6000 c 501 (ul) v.The reporter was able to provide one patient sample with discrepant results: the patient sample was rerun on the c 311 analyzer as the data flag and delta check indicated that the initial na result from the c 501 module was low compared to the patient's previous result.The questionable cl result was not reported outside of the laboratory.The initial cl result from the c 501 was 90.9 mmol/l (91 mmol/l).The repeat result from the c 311 was 102.8 mmol/l.The initial result was deemed correct.

Manufacturer Narrative

Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the last calibration performed on (b)(6) 2024 and the results were within specifications.The customer stated that they believe there are no issues with the analyzer.The investigation determined the event was consistent with a preanalytic issue at the customer site (mis-sampling caused by insufficient aspirated sample volume).Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 19032285
• MDR Text Key: 339241861
• Report Number: 1823260-2024-01020
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (y/n): Y
• 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: 05/21/2024
• 2 Devices were Involved in the Event: 1 2

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: 03246353001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/21/2024
• 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: 49 YR
• Patient Sex: Female