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

Catalog Number	04892470160
Medical Device Problem Codes	Mechanical Problem (1384); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 rack serial number was (b)(6).The field service engineer (fse) found a misaligned sample/reagent probe.He aligned the sample/reagent probe.The fse verified the sample by repeating it and obtaining a correct result.The customer performed calibration and qc and they were acceptable.Precision studies were performed and they were within specifications.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's plasma sample tested with elecsys parathyroid hormone (pth) stat assay on a cobas e411 immunoassay analyzer when compared to a different cobas e411 immunoassay analyzer.Initial result: < 1.2 pg/ml.The physician questioned the result.The sample was repeated.Repeat result: 208.4 pg/ml.
Additional Manufacturer Narrative
The medical device problem code was updated.The last calibration was performed on (b)(6) 2023.The signals were slightly lower than expected but did not appear to affect the performance of the calibration.No qc data was provided but the customer stated that qc was performed on the date of the event and it was acceptable.A general reagent problem can be excluded because the qc was within the ranges prior to the event.The alarm trace showed multiple alarms including premature low level detection (lld) hovering on assay rackpack alarm, sample lld malfunction during movement alarm, and sample volume insufficient or clot pip alarms.On the day of the event, the probe was checked and it was clean and straight.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS PTH STAT IMMUNOASSAY
• 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: 17871237
• Report Number: 1823260-2023-03185
• Device Sequence Number: 20274058
• Product Code: CEW
• UDI-Device Identifier: 04015630939244
• UDI-Public: 04015630939244
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 12/06/2023

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 Catalogue Number: 04892470160
• Device Lot Number: 646241
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/06/2023
• 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