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

Catalog Number	07251068190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The serial number of the e801 analyzer is reported as (b)(6).A review of calibration data showed no calibration influence.Controls were within range prior to sample measurement.A general reagent issue can be excluded.A review of the alarm trace showed some sample clot detection alarms.The investigation is ongoing.
Event or Problem Description
The initial reporter alleged that they received discrepant results for one patient sample tested with elecsys pth on a cobas e 801 analytical unit.The patient's surgery was allegedly stopped due to a reported incorrect pth value.A first sample collected from the patient reportedly resulted in a pth value of 118 pg/ml.During the surgery, a second sample collected from the patient was loaded into a sample cup and tested, reportedly resulting in a pth value of 5.94 pg/ml.The patient's surgery was allegedly stopped due to this value.The second sample was then repeated, reportedly resulting in a pth value of 125 pg/ml.It was reported that this repeat value was reported to the physician.A third sample was collected from the patient on (b)(6) 2025 and tested twice, reportedly resulting in pth values of 112 pg/ml and 99.9 pg/ml.The patient allegedly had a second surgery performed on (b)(6) 2025 and the situation is reported to be stabilized.Samples collected during this surgery were allegedly sent to an external laboratory for testing.The customer alleged that there were differences between results of the same samples sent to the external laboratory and the results obtained with the e801 analyzer.No specific results were provided.
Additional Manufacturer Narrative
The field service engineer cleaned a system reagent syringe and performed flow path cleaning maintenance.A probe was adjusted and the probe wash station was cleaned and adjusted.The number of sample tube inversions performed when preparing the sample was less than recommended by the tube manufacturer.Isolated non-reproducible results do not represent a general malfunction of the assay.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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22035167
• Report Number: 1823260-2025-01516
• Device Sequence Number: 9530356
• 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): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 07251068190
• Device Lot Number: 80171401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/28/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female