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

Catalog Number 03271749190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of imprecise results for 4 patients tested for elecsys hcg + beta test system (hcg + b) on a cobas 6000 e 601 module when testing between serum samples and edta samples.Erroneous results were reported outside of the laboratory.Due to a history of false negative results, the customer confirms all negative hcg + b test results by performing a rapid card test.The rapid card test for all 4 patients was positive.When the patient samples were repeated using the serum samples the results were positive.When the edta samples were repeated the results were negative.The customer thinks there may be an interference in the samples.The negative results support the clinical picture for these patients.The customer provided data for 3 "cases." the data provided within the 3 "cases" is not clear.Clarification on the contents of the 3 cases has been requested but has not been provided."case 1" documents patient id (b)(6) with an hcg + b result from an edta sample of 0.100 miu/ml with a data flag."case 1" also documents that on (b)(46 2017 patient id (b)(6) (female (b)(6)) had an hcg + b result from an edta sample of 0.100 miu/ml with a data flag.The result from the serum sample was 91.05 miu/ml."case 2" documents that on (b)(6) 2017 patient id (b)(6) (female, (b)(6)) initial hcg + b result from an edta sample was 0.100 miu/ml with a data flag.The result from the serum sample was 31.68 miu/ml."case 2" also documents patient id (b)(6) with an hcg + b result from an edta sample of 0.100 miu/ml with a data flag."case 3" documents that on (b)(6) 2017 patient id (b)(6) (female, (b)(6)) initial hcg + b result from an edta sample was 0.100 miu/ml.The sample was repeated and the edta sample result was 0.100 miu/ml.There was no allegation that an adverse event occurred.The e601 module serial number was not provided.

Manufacturer Narrative

The ages initially provided in the report were obtained from the data provided by the customer.The customer has clarified that these ages are not correct.The ages for the affected patients were not provided.Age/date of birth was corrected.Relevant tests/lab data was corrected.The customer has clarified the description of events for 3 of the patient samples.(b)(6).

Manufacturer Narrative

The customer provided the results for the 4th patient sample.On (b)(6) 2017 patient 4 initial hcg + b result from an edta sample was 0.100 miu/ml with a data flag.The result from the serum sample was 30.67 miu/ml.

Manufacturer Narrative

The investigation received a serum and plasma aliquot for all 4 patients involved in this event.A specific root cause could not be identified.The plasma samples that were sent were either whole blood or extremely hemolytic.This sample material may not be valid for the hcg + b assay.Due to the quality of the plasma samples, the results generated do not indicate a product problem.A general reagent issue can be excluded.Further clarification of the issue is not possible with the available information.

• 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: 6706690
• MDR Text Key: 80056418
• Report Number: 1823260-2017-01455
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K003178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 03271749190
• Device Lot Number: 15654201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• 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: 30 YR