MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE ELECSYS PTH TEST SYSTEM; PARATHYROID HORMONE TEST SYSTEM

Catalog Number 08928410190

Device Problem High Test Results (2457)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

The e602 module serial number was (b)(6).The competitor method was liaison xl.The sample was requested for investigation.

Event Description

The initial reporter complained of high results not corresponding to the clinical status for 1 patient sample tested for elecsys pth stat (pth stat) on a cobas 8000 e 602 module.The following results were from the e602 module: the initial result was 413 ng/l.The result using ½ dilution was 292.7 ng/l.The result using ¼ dilution was 170 ng/l.The result with veraprep treatment was 470 ng/l.The result with polyethylene glycol (peg) treatment was 11 ng/l.The result from a competitor method was 345 ng/l.The customer suspects an interference.

Manufacturer Narrative

The sample was received for investigation.The sample was tested on an e602 module with pth stat reagent lot 722334 and pth 1-84 reagent lot 733232.The sample was tested untreated and after heterophilic blocking tube (hbt) treatment.Pth 1-84: 200.3 pg/ml (untreated), 203.2 pg/ml (after hbt treatment) pth stat: 385.6 pg/ml (untreated), 390.3 pg/ml (after hbt treatment) the investigation confirmed the customer's high pth stat results.The sample was investigated further by size exclusion chromatography (sec).The investigation results suggest the presence of igg antibodies leading to the formation of a macromolecule igg - pth which was detected by the elecsys pth stat assay and the competitor assay.Product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• Brand Name: ROCHE ELECSYS PTH TEST SYSTEM
• Type of Device: PARATHYROID HORMONE TEST SYSTEM
• 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: 18672408
• MDR Text Key: 334952550
• Report Number: 1823260-2024-00380
• Device Sequence Number: 1
• Product Code: CEW
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08928410190
• Device Lot Number: 72233401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• 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