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

Catalog Number 07251068190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e 801 analyzer is (b)(6).Calibration signals were within expectations.Controls recovered within range on the day of sample measurement.Upon review of the alarm trace, a sample short alarm was observed.Performance testing run on (b)(6) 2023 failed.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys pth on a cobas e 801 analytical unit.The sample initially resulted in a pth value of 6.56 pg/ml.The doctor questioned the result as the patient had a previous pth value of 199 ng/ml.The sample was repeated, resulting in a value of 267 pg/ml.

Manufacturer Narrative

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: 18162954
• MDR Text Key: 328433252
• Report Number: 1823260-2023-03658
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: 70634601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• 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