MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PTH ELECSYS E2G 300; PARATHYROID HORMONE ASSAY

Catalog Number	08928428190
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	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas pure e 402 analytical unit is 22m8-07.Investigation is ongoing.
Event or Problem Description
There was an allegation of questionable pth results with one patient sample on a cobas pure e 402 analytical unit.The initial result was 25.8 pg/ml using the secondary tube.The repeat result was 523 pg/ml using the primary tube.The second repeat result was 609 pg/ml using the same secondary tube.The third repeat result was 571 pg/ml using a different secondary tube.The initial result did not fit the patient's clinical picture, therefore, the repeat testings were performed.The repeat results were deemed correct.
Additional Manufacturer Narrative
A general reagent problem was excluded as the qc prior to the event was within ranges.A review of the alarm trace showed few sample clot alarms at the time of sample pipetting.Additionally, the initial low result was flagged with a sample air bubble detected alarm.Note, bubbles on the sample surface may lead to mis-pipetting and non-reproducible results (also in combination with tilted tubes and liquid on the tube wall).The investigation did not identify a product problem.

• Brand Name: PTH ELECSYS E2G 300
• Common Device Name: PARATHYROID HORMONE ASSAY
• 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: 20352934
• Report Number: 1823260-2024-02850
• Device Sequence Number: 8000058
• Product Code: CEW
• UDI-Device Identifier: 07613336170304
• UDI-Public: 07613336170304
• Combination Product (Y/N): Y
• Initial Reporter Country: WZ
• 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): 10/17/2024

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: 08928428190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/17/2024
• 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