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

Catalog Number	11972103160
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The field service representative replaced seals on the instrument but he did not find a product problem.He performed tests with acceptable results.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys pth results for 1 patient on a cobas e 411 analyzer (disk system).Sample 1: the initial result was 1276 pg/ml and the repeated result was 1289 pg/ml.Sample 2: the initial result was 10.26 pg/ml and the repeated result was 1041 pg/ml.Sample 3: the initial result was 1296 pg/ml and the repeated result was 1314 pg/ml.Sample 4: the initial result was 968.6 pg/ml and the repeated result was 1003 pg/ml.The questionable results were reported outside the laboratory.The repeated results were obtained on another module and were believed to be correct.The samples were repeated as the initial result from the second sample was much lower than expected.
Additional Manufacturer Narrative
The investigation did not identify a product problem.Based on the information provided, 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: 20653933
• Report Number: 1823260-2024-03256
• Device Sequence Number: 20493295
• Product Code: CEW
• UDI-Device Identifier: 04015630939237
• UDI-Public: 04015630939237
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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: 11972103160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/20/2024
• 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