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

Catalog Number 07251025190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

The initial reporter received a questionable elecsys hcg + beta test system result for one patient sample tested on a cobas e 801 analytical unit with serial number (b)(4).The sample was rerun on another e 801.It was also sent out to another laboratory that uses a siemens analyzer with chemilluminescence as the laboratory method.On (b)(6) 2021, sample id (b)(6) had an initial result from the analyzer at 6:03 pm of 10000 miu/ml with a data flag.The first repeat result at 6:39 pm at 1:100 dilution was 1000000 miu/ml with a data flag.The second repeat result at 7:23 pm at 1:400 dilution was 1711693 miu/ml.This result was reported to the medical personnel.On (b)(6) 2021 at 10:39 am, the third repeat result from the analyzer at 1:400 dilution was 1911839 miu/ml.The fourth repeat result from the other e 801 at 1:100 dilution was 1000000 miu/ml with a data flag.The fifth repeat result from the other e 801 at 1:400 dilution was 2063432 miu/ml.The initial result from the siemens analyzer was 645 miu/ml.The repeat result was 727.2 miu/ml.

Manufacturer Narrative

The sample was requested for investigation but is no longer available.Upon investigation of the submitted data, a general reagent problem can be excluded because the provided qc data were within specifications.The calibration trace was within specifications.It was confirmed that the alarm trace did not indicate an issue on the day of the event.The patient was diagnosed to have a hydatidiform mole.Product labeling states: "elevated values here serve as an indication of chorionic carcinoma, hydatidiform mole or multiple pregnancy." the investigation did not identify a product problem.

• Brand Name: ELECSYS HCG + BETA TEST SYSTEM
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13358118
• MDR Text Key: 289956709
• Report Number: 1823260-2022-00208
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 04015630939732
• UDI-Public: 04015630939732
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K003178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 07251025190
• Device Lot Number: 513851
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female