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

Catalog Number 03271749160

Device Problems Unable to Obtain Readings (1516); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys hcg+b results from an unspecified number of patient samples tested on the cobas e411 disk.The reporter stated that they monitor the hcg+b results and rerun the patient samples with low results as they have been having issues with the assay.The reporter stated that their qc was also running low.The reporter was able to provide one example of discrepant results: the initial result was not reported outside of the laboratory.The initial result was 0.100 miu/ml with a data flag.The first repeat result was 10.74 miu/ml.The second repeat result was 12.18 miu/ml.This repeat result was deemed correct and reported. .

Manufacturer Narrative

The serial number of the customer's cobas e411 disk is (b)(6).The field service engineer inspected the analyzer and determined that the event was consistent with a bubble aspirated by the sample or reagent probe from either the sample tube or reagent pack.The fse performed a system volume check with successful results.He performed instrument and mechanical checks with successful results.The fse confirmed that the analyzer was performing within specifications.The investigation is ongoing.

Manufacturer Narrative

Medwatch fields d.Device identification and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the last calibration performed on (b)(6) 2023; the signals were slightly lower than the expected signals but did not appear to affect the performance of the calibration; no alarms were noted.The investigation reviewed the qc data; the qc was within the assigned ranges on the day of event.The investigation reviewed the alarm trace; a "sample liquid-level detection (lld) alarm" was noted after aspiration.The investigation determined a general reagent problem was not present because the qc before the event was within ranges.Based on the information provided, the cause of the event could not be determined.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS HCG+B
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17808161
• MDR Text Key: 324144134
• Report Number: 1823260-2023-03084
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03271749160
• Device Lot Number: 66436305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• 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: 35 YR
• Patient Sex: Female