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

Catalog Number	08890595190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient sample tested for elecsys hcg stat (hcg stat) on a cobas e 402 analytical unit.The customer questions the difference in the results from the heparin tube and the "dry" tube.Of the data provided, discrepant results for cobas creatinine plus ver.2 assay (crep2) were also generated for this patient sample.This medwatch will cover hcg stat.Refer to medwatch with a1 patient identifier (b)(6) for information on the crep2 results.All results are from the same sample.The hcg stat results from the heparin tube were 734.00 iu/l, 833.00 iu/l, and 264.00 iu/l.The hcg stat results from the "dry" tube were < 1.00 iu/l with a data flag.These results are believed to be correct as the patient is not pregnant.The crep2 result from the heparin tube was 454 umol/l.The crep2 result from the "dry" tube was 65.3 umol/l.The heparin tube was recentrifuged and run in a hitachi cup with an hcg stat result of 273 iu/l and a crep2 result of 449 umol/l.The results from the heparin tube are in question.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Hcg stat calibration was last performed on (b)(6) 2024 with acceptable results.Hcg stat qc was acceptable.During a review of the alarm trace data, 4 sample-related alarms were observed.These alarms are indicators of possible sample quality issues.Based on the information available, the investigation determined the event was consistent with a sample quality issue for the heparin plasma sample.The investigation did not identify a product problem.

• 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: 19297613
• Report Number: 1823260-2024-01422
• Device Sequence Number: 6015692
• Product Code: DHA
• UDI-Device Identifier: 07613336169223
• UDI-Public: 07613336169223
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 06/14/2024

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 Expiration Date: 03/31/2025
• Device Catalogue Number: 08890595190
• Device Lot Number: 768087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ROACCUTANE
• Patient Age: 17 YR
• Patient Sex: Female