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

Catalog Number	08890587190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys hcg stat (hcg stat) on a cobas e 411 analyzer (rack system).The initial result was <0.500 miu/ml with a data flag.The sample was repeated as the patient complained.The repeat result was 326.3 miu/ml.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The e411 analyzer serial number was (b)(6).The field service engineer (fse) completed instrument performance testing with acceptable results.A cause for the issue was not identified.The investigation is ongoing.
Additional Manufacturer Narrative
The last calibration performed on (b)(6)2023 was ok and there were no alarms.Quality controls were within range.There was no indication of a reagent performance issue.The investigation could 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 (HCG) TEST SYSTEM
• 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: 17977904
• Report Number: 1823260-2023-03384
• Device Sequence Number: 2505136
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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: 07/31/2024
• Device Catalogue Number: 08890587190
• Device Lot Number: 66347601
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/10/2023
• 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: 40 YR
• Patient Sex: Female