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

Catalog Number 07251068190

Device Problem High Test Results (2457)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

The customer's e 801 analyzer serial number is (b)(6).The serial number of the e 801 analyzer used for investigation was requested, but not provided.The investigation is ongoing.

Event Description

The initial reporter stated they received questionable results for one patient sample tested with elecsys pth on two cobas e 801 module analyzers.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2023.The customer repeated the sample with x2, x4, and x8 dilutions.The patient's previous pth values ranged between 50 and 100 pg/ml, so the results from the complained sample were questioned.The sample was provided for investigation where it was tested with pth and pth (1-84) on a second e 801 analyzer on (b)(6) 2023.Pth and pth (1-84) were also re-measured after x2, x4, and x8 manual dilutions with both low pth patient serum and diluent solution.

Manufacturer Narrative

Calibration and control data were acceptable.There was no indication of a reagent issue.The sample was not available for further investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 18107005
• MDR Text Key: 328650120
• Report Number: 1823260-2023-03571
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07251068190
• Device Lot Number: 706346
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• 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