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

Catalog Number 03300811190

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 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they have been getting questionably low results for four samples from the same patient tested with the elecsys hcg test system ver.2 on a cobas e 411 immunoassay analyzer (serial number (b)(4)).A fifth sample from the same patient also had a questionable result when tested for hcg on an unknown roche cobas analyzer at a second site.All sample results were reported outside of the laboratory.The values for the patient have been consistently low and the physician questions if the samples contain an interferent to the assay.The specific date of the event is not known.In (b)(6) 2021, a first sample from the patient resulted in an hcg value of 2.4 miu/ml.A few weeks after the first sample, a second sample from the patient resulted in an hcg value of 1.8 miu/ml.A few weeks after the second sample, a third sample from the patient resulted in an hcg value of 1.3 miu/ml.On (b)(6) 2021, a fourth sample from the patient resulted in an hcg value of 1.0 miu/ml.The sample was also serially diluted and repeated, resulting in the following values: 1:2 dilution = 1.3 miu/ml, 1:5 dilution = 2.9 miu/ml, 1:10 dilution = 7.9 miu/ml, 1:20 dilution = 19.0 miu/ml, 1:50 dilution = 48.8 miu/ml, 1:100 dilution = 150.2 miu/ml.A fifth sample from the patient was collected on (b)(6) 2021 and sent to a second site to be tested for heterophile antibodies to hcg.This test resulted as "not detected".At the second site, the sample was also tested on an unknown roche cobas analyzer, resulting in a hcg value of 2.3 iu/l.At the second site, the sample was repeated on a beckman coulter analyzer, resulting in a value of 2.7 iu/l.Hcg reagent lot 528065 was used on the customer's e411 analyzer.The expiration date for this lot was requested, but not provided.The hcg reagent lot and expiration date used on the unknown roche cobas analyzer at the second site were requested, but not provided.

Manufacturer Narrative

Quality control recovery was acceptable.The provided patient results were within expected values.Product labeling states: "expected values: 1 miu/ml hcg for 97.5 % of the values obtained from 182 healthy, non-pregnant premenopausal women.The corresponding upper 95 % confidence limit ranges up to 4.9 miu/ml.7 miu/ml hcg for 97.5 % of the values obtained from 143 healthy, postmenopausal women.The corresponding upper 95 % confidence limit ranges up to 8.1 miu/ml." sample dilution at the low end of the assay measuring range is not recommended.The provided dilution results can be explained by the very low endogenous analyte concentration of the diluent.The instrument calculates the dilution factor despite the results are below measuring range.Product labeling states: "samples with hcg concentrations above the measuring range can be diluted with diluent universal.The recommended dilution is 1:100 (either automatically by the analyzers or manually).The concentration of the diluted sample must be > 100 miu/ml." the investigation could not identify a product problem.The assay is working within specifications.

• Brand Name: ELECSYS HCG TEST SYSTEM
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12420760
• MDR Text Key: 273116674
• Report Number: 1823260-2021-02579
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 04015630919383
• UDI-Public: 04015630919383
• Combination Product (y/n): N
• PMA/PMN Number: K002148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03300811190
• Device Lot Number: 528065, ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR