MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HUMAN CHORIONIC GONADOTROPIN, STAT (SHORT TURN AROUND TIME); SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number 03300811190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that a clinical euthyroid patient has been seen by their endocrinologist over the years and the blood work for this patient has been unusual, with no clear explanation.The patient is postmenopausal, but lh and fsh are markedly elevated.The patient's pth is elevated (40-50 pmol/l) without any evidence of hypercalcemia and the patient's prolactin is up to 171.2 ng/ml, with a normal mri.The main issue is that there is multiple elevation of hormones, but without clinical presentation and other investigative evidence.To investigate the issue, a sample from the patient was treated with a heterophilic antibody blocking tube (hbt), but this did not indicate any interference.Dilution studies also did not show any apparent interference.Polyethylene glycol precipitation (peg) of a sample from the patient did identify a potential interference with macro-tsh or macro-lh.A sample of the patient from (b)(6) 2015 was investigated and the investigation results of this sample were provided.Refer to the attachment for the investigation results.The sample was tested for thyrotropin (tsh), free thyroxine (ft4), free triiodothyronine (ft3), follicle-stimulating hormone (fsh), lutenizing hormone (lh), prolactin (prl), and human chorionic gonadotropin stat (short turn around time) - hcg on an e170 analyzer.The sample was also treated with hbt, diluted 1:2, diluted 1:5, diluted 1:10, treated with peg, and also tested on an abbott architect analyzer.Of the results provided, the sample was found to have erroneous results for tsh, ft3, and hcg.The date of the event was asked for, but not provided.No erroneous results were reported outside of the laboratory.This medwatch will cover hcg.Please refer to the medwatch with (b)(6) for information related to tsh and medwatch with (b)(6) for information related to ft3.The patient was not adversely affected.The sample was tested on an e170 analyzer, serial (b)(4).

Manufacturer Narrative

Investigations have not determined any indication of an interference.Serum fractionation of the sample found that the respective analytes of tsh, prl, lh, and pth were present where they would be expected according to molecular weight in the fractions.

Manufacturer Narrative

Investigations have determined that the measured concentrations for pth, prolactin, lh, and tsh at the customer's site must be considered correct.The peg precipitation experiment conducted by the customer could not be assessed as details from this experiment were limited.

• Brand Name: HUMAN CHORIONIC GONADOTROPIN, STAT (SHORT TURN AROUND TIME)
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 4996707
• MDR Text Key: 25055773
• Report Number: 1823260-2015-03942
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K002148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 07/16/2015
• 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