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

Model Number	PTH
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon review of the calibration data, signals below the lower expected values were observed.Quality controls were acceptable.The alarm trace did not show an alarm related to the event.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys pth assay on a cobas e 801 module, serial number (b)(6).The sample initially resulted in a pth value of 84.4 pg/ml.The sample was repeated two times, resulting in pth values of 70.5 pg/ml and 69.0 pg/ml.On (b)(6) 2023, the sample was centrifuged and sent to another laboratory using an e801 module.The repeat result from a secondary tube was 20.8 pg/ml.It was asked but it is unknown if a questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The sample was not frozen between the testing performed on (b)(6) 2023 and (b)(6) 2023.Product labeling states: "serum: stable for 8 hours at 15-25 °c, 2 days at 2-8 °c, 6 months at -20 °c (± 5 °c)." since the sample was stored at 2-8 °c for >2 days, sample stability is no longer guaranteed.The customer used a centrifugation speed of 3500 g for 5 minutes.Based on the type of sample tubes the customer uses, a centrifugation speed of 3000 g for 5 minutes or 1800 g for 10 minutes is recommended.The sample was recentrifuged prior to running the test on (b)(6) 2023.From the data provided, a general reagent issue can be excluded.The investigation determined the root cause of the event was a pre-analytical handling issue (inappropriate sample handling between testing dates).

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17016416
• Report Number: 1823260-2023-01771
• Device Sequence Number: 15235403
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 06/16/2023

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 Expiration Date: 12/31/2023
• Device Model Number: PTH
• Device Catalogue Number: 07251068190
• Device Lot Number: 646246
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 05/29/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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