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

Catalog Number	08890587190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys hcg stat (hcg stat) results from three patient samples tested on the cobas e411 rack.On (b)(6) 2023: sample (b)(6).The patient sample was sent to a sister laboratory that also uses elecsys hcg stat and an e 411 for checking before reporting the result to the physician.The initial result of the undiluted sample from the analyzer was >10000 miu/ml.With a data flag.The first repeat result from the analyzer on auto dilution was 291.2 miu/ml.The second repeat result of the undiluted sample from the sister laboratory's e 411 was >10000 miu/ml.The third repeat result of a diluted sample from the sister laboratory's e 411 was 24994 miu/ml.A result of 24995 miu/ml from the sister laboratory was reported to the doctor.On (b)(6) 2023, the field service engineer inspected the analyzer and checked the solutions.He also performed a mixing check.He performed the necessary adjustments to the mixer and the sample/reagent (s/r) probes.He checked the s/r voltage and noted that the results with a tip and without a tip were inverse.He then performed a voltage adjustment on the liquid-level detection (lld) board.Calibrations and qcs were performed.The issue was not resolved.Discrepant results were again reported.On (b)(6) 2023: sample (b)(6).The initial result of the undiluted sample from the analyzer was >10000 miu/ml with a data flag.The first repeat result with the patient sample at 1:100 dilution from the analyzer was 278.2 miu/ml with a data flag.The second repeat result of the undiluted patient sample from the analyzer was >10000 miu/ml with a data flag.The third repeat result with the patient sample at 1:100 dilution from the analyzer was 358.7 miu/ml with a data flag.The fourth repeat result with the patient sample at 1:10 dilution from the analyzer was 18086 miu/ml with a data flag.The fifth repeat result with the patient sample at 1:2 dilution from the analyzer was 18073 miu/ml with a data flag.The sixth repeat result with the patient sample at 1:5 dilution from the analyzer was 17332 miu/ml with a data flag.The result of the diluted patient sample from the sister laboratory was "183 000".On (b)(6) 2023: sample (b)(6).The initial result of the undiluted sample from the analyzer was >10000 miu/ml with a data flag.The first repeat result with the patient sample at 1:100 dilution from the analyzer was 328.7 miu/ml with a data flag.The second repeat result with the patient sample at 1:100 dilution from the analyzer was 348.6 miu/ml with a data flag.The third repeat result of the undiluted patient sample from the analyzer was >10000 miu/ml with a data flag.The fourth repeat result with the patient sample at 1:50 dilution from the analyzer was 163.3 miu/ml with a data flag.The fifth repeat result with the patient sample at 1:20 dilution from the analyzer was 63.94 miu/ml with a data flag.The sixth repeat result with the patient sample at 1:10 dilution from the analyzer was >10000 miu/ml with a data flag.The result of the diluted patient sample from the sister laboratory was "360 143".
Additional Manufacturer Narrative
The serial number of the customer's cobas e411 rack is (b)(6).On the field service engineer's (fse) second service visit, he noted that the sample/reagent (s/r) probe tube was out of the pulley.He also found one of the signals to be high during the first run of a precision check which he thought was probably due to a change in the blank cell value.He then performed another precision check.He also cleaned the tip/cup buffer using an alcohol swab.He performed vertical and horizontal adjustments of the s/r probe at the buffer and bottom adjustment of the s/r probe sample cup.He checked all the s/r probe adjustments at the reagent carousel and performed the vertical adjustment of the sipper nozzle.He also replaced the pinch valve tubing.He reloaded the system software (for troubleshooting purposes), ran high voltage checks, and adjusted to close to 82000 counts.He performed another precision check with successful results.He also performed the initial blank cell calibration with successful results.He deleted all previous calibrations and updated the reference data file.The customer performed calibrations and qcs for all assays with successful results.They ran a "dummy" sample for hcg with a result of >10000 miu/ml and diluted the sample by 1:100 and the result was acceptable at 15000 miu/ml.The fse instructed the customer to perform a 1:100 manual dilution of a sample and the result was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.The specific cause of the event could not be determined.

• Brand Name: ELECSYS HCG STAT
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM
• 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: 18099829
• Report Number: 1823260-2023-03562
• Device Sequence Number: 12680291
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• 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): 12/06/2023

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: 07/31/2024
• Device Catalogue Number: 08890587190
• Device Lot Number: 663476
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 34 YR
• Patient Sex: Female
• Patient Race: Black Or African American