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

Catalog Number 03271749160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer obtained questionable high elecsys hcg + beta test system (hcg+b) results using the analytical e module (serial (b)(4)) for two female patients who were not pregnant.Of the data provided, the results for patient a were discrepant.The customer initially believed the results to be true positives due to possible tumors secreting hcg+b.The customer states that the hcg+b results "reduced over time" after treatment with methotrexate.All results are in units of miu/ml, and all were released outside the laboratory.No data flags or alarms occurred.Patient a: the initial sample was drawn (b)(6) 2017 and analyzed (b)(6) 2017.The initial result was 36; repeat results were 35 and 35.A second sample was drawn (b)(6) 2017 and analyzed (b)(6) 2017.The initial result was 37; repeat results were 38 and 38.The patient and physician had performed "spot" (random) urine pregnancy tests that were also positive.On an unspecified date, the patient underwent an ultrasound which was negative, and she was treated with methotrexate.The patient was not adversely affected.The customer requested investigational confirmation testing for the samples.No samples from patient a were received, and the clinician stated he did not require additional testing.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

Manufacturer Narrative

Medical assessment of the event stated there is a lag time in the detect-ability of pregnancy between an hcg + b test and an ultrasound result.It is likely that the patient was in the early stages of pregnancy resulting in a negative ultrasound result.A product problem was not identified.

• 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: 6785440
• MDR Text Key: 83278621
• Report Number: 1823260-2017-01673
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• 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: 179825
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR