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

Catalog Number	07251068190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2023-03571
• Device Sequence Number: 18050689
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K070709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07251068190
• Device Lot Number: 706346
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown