MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+B; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	HCG+BETA
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hcg+b results for 1 patient sample on a cobas e 601 module.There was an allegation of a suspected interference with the elecsys hcg+b assay.The initial result was 15.15 miu/ml.The sample was tested in another laboratory using an e601 module and the results were 14.98 miu/ml and 14.67 miu/ml.The sample was tested using the abbott method and the result was <1.2 miu/ml (negative).The sample was tested using the mindray method and the result was <0.5 miu/ml (negative).The questionable results were not reported outside the laboratory.The sample was repeated as the questionable results did not match the patient's clinical diagnosis.
Additional Manufacturer Narrative
E1 initial reporter street: block b, building 3, (b)(6).The customer's e601 analyzer serial number is (b)(6).The serial number for the other e601 analyzer was not provided.The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc were acceptable.The patient sample was investigated.The investigation results were: elecsys hcg+b: 15.495 miu/ ml free hcg: 0.100 iu/l with a data flag hcg-stat: 16.65 miu/ ml.Discrepant high hcg results compared to a competitor (abbott mindray) are due to the different epitope recognition for the antibodies of the different assays.An assay interference was excluded.The investigation did not identify a product problem.

• Brand Name: ELECSYS HCG+B
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: 20738850
• Report Number: 1823260-2024-03378
• Device Sequence Number: 8287009
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K003178
• 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): 12/20/2024

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: 07/31/2025
• Device Model Number: HCG+BETA
• Device Catalogue Number: 03271749160
• Device Lot Number: 774930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/20/2024
• 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
• Patient Age: 7 YR
• Patient Sex: Female