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

Model Number	HCG+BETA
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure e 402 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys hcg+b results from two patient samples tested on the cobas pure e 402 analytical unit.Patient sample 1: the initial result was 4.05 miu/ml.The repeat result was 39.2 miu/ml.Patient sample 2: the initial result from the analyzer was 25.9 miu/ml.The repeat result from a cobas c 601 was 6.99 miu/ml.The repeat result from the analyzer was <3 miu/ml.
Additional Manufacturer Narrative
The investigation reviewed the calibration, qc data, alarm trace, instrument log and preanalytical handling data: the calibration data shows an alarm that indicates calibrator handling issues.The qc results are within the specified ranges.The alarm trace has multiple sample clot alarms over the last 30 days, indicating sample handling issues.The instrument log shows contamination in the pipetting stations, and several deionized water supply errors occurred around the date of event.The preanalytical handling data shows that the patient sample tube was not inverted, the tube manufacturer specified 5 to 6 inversions; the patient sample was coagulated for 10 minutes, the tube manufacturer specified 30-60 minute coagulation time; the patient sample was centrifuged for 5 minutes at 5000 rpm, the tube manufacturer specifies a centrifugation time of 10 minutes at max 1300 g (up to 2000g).The investigation determined the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22174911
• Report Number: 1823260-2025-01778
• Device Sequence Number: 15411248
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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): 07/07/2025

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: 09/30/2025
• Device Model Number: HCG+BETA
• Device Catalogue Number: 07251025190
• Device Lot Number: 792314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/07/2025
• 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 Sex: Unknown