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

Catalog Number 04892470190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

There was an allegation of a questionable pth stat elecsys result from the cobas e411 rack analyzer.The initial result was 1.58 pmol/l.The repeat results were 9.78 pmol/l and 9.72 pmol/l.The result of 9.78 pmol/l was reported outside of the laboratory as it met the clinical picture of the patient.

Manufacturer Narrative

The cobas e411 rack serial number was (b)(6).The investigation is ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The event was consistent with a preanalytic issue as the customer did not invert the plasma tube and the centrifugation settings were possibly not in accordance with the tube manufacturer's recommendations.

• Brand Name: ELECSYS PTH STAT
• 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: 18337039
• MDR Text Key: 330677226
• Report Number: 1823260-2023-04051
• Device Sequence Number: 1
• Product Code: CEW
• Combination Product (y/n): Y
• Reporter Country Code: SF
• PMA/PMN Number: K070709
• 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
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04892470190
• Device Lot Number: 646241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• 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: 44 YR
• Patient Sex: Female