MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PTH; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Catalog Number 11972103160

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

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

The pth reagent expiration date was not provided.The cobas e411 rack serial number was (b)(6).The field service engineer found that the tip buffer sensor was dirty and the measuring cell was degraded.He cleaned the sensor and replaced the measuring cell.He then ran the assay testing and performed all checks and they were successful.The customer performed calibration and qc and they were acceptable.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's plasma sample tested with elecsys parathyroid hormone (pth) assay on a cobas e411 immunoassay analyzer.Initial result: 10.17 pg/ml.Repeat result: 342.7 pg/ml.The initial result was automatically reported outside the laboratory.The technician then repeated the sample as the result did not match the patient's medical history.The technician reportedly called the doctor with the correct repeat result.

Manufacturer Narrative

The cause was the dirty tip buffer sensor in the second tip position and the degrading measuring cell.The service actions (cleaning the sensor and replacing the measuring cell) resolved the issue.No further issues were reported afterward.

• Brand Name: ELECSYS PTH
• Type of Device: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• 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: 18917338
• MDR Text Key: 337819946
• Report Number: 1823260-2024-00780
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 04015630939237
• UDI-Public: 04015630939237
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K070709
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11972103160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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