MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS AMH; ANTI-MÜLLERIAN HORMONE TEST SYSTEM

Catalog Number	07026714190
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	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) inspected the analyzer and did not find any hardware issues.He then performed an instrument check with acceptable results.He did not perform any repairs.The customer performed qc with acceptable results.The analyzer's performance was verified.
Event or Problem Description
The initial reporter received questionable elecsys amh (amh) results for two patient samples tested on the cobas e 801 analytical unit with serial number (b)(4).The initial results were reported outside of the laboratory.The reporter was performing a qc investigation for low bias of the amh assay.The reporter used old proficiency material for repeats and it was confirmed that there was a low bias.The reporter then sent out the patient samples to a laboratory that uses a roche elecsys analyzer for a split-sample analysis.Patient 1: the initial result from the analyzer was 6.83 ng/ml.The repeat result from the other laboratory was 11.61 ng/ml.Patient 2: the initial result from the analyzer was 12.1 ng/ml.The repeat result from the other laboratory was 35.3 ng/ml.The repeat results were deemed correct.
Additional Manufacturer Narrative
The last calibration performed on 14-aug-2022 was within specifications.The qc recovery was within -2sd and within specifications.There is no indication of a performance issue with the reagent.The customer sent out new samples for further comparison testing and found them all to be within their laboratory's acceptable limits.After the instrument's performance was verified, no further issues were reported by the customer.  the investigation determined the issue was resolved.The cause of the event could not be determined. .

• Brand Name: ELECSYS AMH
• Common Device Name: ANTI-MÜLLERIAN HORMONE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15633181
• Report Number: 1823260-2022-03255
• Device Sequence Number: 17629453
• Product Code: PQO
• UDI-Device Identifier: 04015630940363
• UDI-Public: 04015630940363
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 11/14/2022

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 Expiration Date: 11/30/2022
• Device Catalogue Number: 07026714190
• Device Lot Number: 58177701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 11/14/2022
• 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: Female