MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG STAT; HUMAN CHORIONIC GONADOTROPIN TEST

Catalog Number	08890595190
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	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e801 immunoassay analyzer serial number was (b)(6).The last calibration was performed on (b)(6) 2023 and the signals were not within specifications.The qc was within ranges prior to the event.On (b)(6) 2023, the alarm trace showed multiple alarms including a sample clot detection, abnormal aspiration, cleancell short and preclean short alarms.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 patient samples tested with elecsys hcg stat assay on a cobas e801 immunoassay analyzer.Sample 1 (patient 1) was tested on (b)(6) 2023: initial result: 2.66 miu/ml.The physician questioned this result as it did not match the patient's medical diagnosis of an ectopic pregnancy and requested that the sample be re-tested.1st repeat result: >10000 miu/ml (original sample re-tested on a different e801 analyzer).2nd repeat result: around 68000 miu/ml (tested on a competitor instrument).3rd repeat result on (b)(6) 2023: 48124 miu/ml (tested with a 100 dilution on the e801 module in question).Sample 2 (patient 2) was tested on (b)(6) 2023: initial result: 1.68 miu/ml.Repeat result: 10000 miu/ml accompanied by a data flag.
Additional Manufacturer Narrative
A general reagent problem can be excluded because the qc prior to the event was within ranges.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HCG STAT
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN TEST
• 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: 17856003
• Report Number: 1823260-2023-03157
• Device Sequence Number: 3353053
• Product Code: DHA
• UDI-Device Identifier: 07613336169223
• UDI-Public: 07613336169223
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• PMA/510(K) Number: K203227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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 Expiration Date: 06/30/2024
• Device Catalogue Number: 08890595190
• Device Lot Number: 66345901
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/30/2023
• 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 Age: 31 YR
• Patient Sex: Female