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

Catalog Number	07229569190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned results for 1 male patient tested for elecsys hcg + b (hcg + b) and elecsys hcg stat (hcg stat) on a cobas e801 module.Based on the data provided, the hcg stat results are a reportable malfunction.The initial hcg stat result from the e801 module was 2.96 miu/ml.This result was reported outside of the laboratory.The sample was sent to an external laboratory using the siemens method and the hcg result was 10.7 miu/ml.The sample was submitted for investigation and tested on an e801 module at the investigation site.The hcg stat result was 2.61 miu/ml which corresponded to the customer's result.There was no allegation that an adverse event occurred.The e801 module serial number used at the customer site was (b)(4).The e801 module serial number used at the investigation site was (b)(4).The hcg stat reagent lot number used at the investigation site was 319823 with an expiration date of 31-jul-2019.Calibration and qc at the investigation was acceptable.Based on the data available, a reagent issue was not identified.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The customer provided additional samples from the patient obtained on (b)(6) 2018 and (b)(6) 2018 for investigation.Based on the data provided, the hcg stat results from the (b)(6) 2018 were discrepant when tested by the e801 module used at the investigation site and the siemens method.The hcg stat result from the e801 module used at the investigation site was < 1.00 miu/ml.The result from the siemens method was 2.1 miu/ml.

• Brand Name: ELECSYS HCG TEST SYSTEM
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8047287
• Report Number: 1823260-2018-04125
• Device Sequence Number: 19279468
• Product Code: DHA
• UDI-Device Identifier: 04015630940417
• UDI-Public: 04015630940417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 07/31/2019
• Device Catalogue Number: 07229569190
• Device Lot Number: 319823
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR