MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROLACTIN ASSAY; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Catalog Number 07027737190

Device Problem Low Test Results (2458)

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

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of results for 1 patient tested for elecsys prolactin ii (prolactin ii) on a cobas e801 module that did not correspond to the clinical history of the patient.The initial prolactin ii result from the e801 module was 7.35 ng/ml and was reported outside of the laboratory> the result was questioned by the physician as the patient had symptoms related to high prolactin results (galactorrhea and evaluation of a brain tumor).The patient was undergoing a biopsy for a possible diagnosis of prolactionoma.The sample was repeated at a different laboratory using the siemens centaur method and the result was 4.9 ng/ml.On (b)(6) 2018 the sample was diluted by the instrument with the following results: 1:50 result 12.0 ng/ml; 1:100 result 15.9 ng/ml; 1:900 result 95.8 ng/ml.The sample was manually diluted with the following results: 1:1 result 3.01 ng/ml; 1:10 result 8.45 ng/ml; 1:100 result 1:100 18.1 ng/ml; 1:1000 result 104 ng/ml.The sample was also repeated at a different laboratory using the siemens centaur method and the result was 4.9 ng/ml.The customer is not sure which result or results are correct.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).

Manufacturer Narrative

The qc data provided by the customer was acceptable.It was determined that the initial prolactin ii result of 7.35 ng/ml was correct.The customer's increasing prolactin ii results were caused by diluting a sample that was within the measuring range and that did not qualify for dilution.The difference in the initial result of 7.35 ng/ml and the result of 3.01 ng/ml was due to the peg treatment.Product labeling addresses sample dilution and peg treatment.It is not known if the centaur result was generated with or without peg treatment.

Manufacturer Narrative

The customer thinks there may be macro prolactin or some kind of interference in the patient sample.Based on the information provided, a general interference in the patient sample is not suspected.Samples with prolactin concentrations above the measuring range can be diluted.The recommended dilution is 1:10.The concentration of the diluted sample must be > 50 uiu/ml or > 2.4 ng/ml.In this case, the sample was neither above the measuring range nor > 2.4 ng/ml after dilution and before the final result calculation.The customer's increasing results were caused by diluting a sample that was within the measuring range and diluted with very high dilution factors (1:50 and higher).If the customer suspects an interference, product labeling advises to perform peg precipitaiton testing and not dilution testing: "in case of implausible high prolactin values a precipitation by polyethylene glycol (peg) is recommended in order to estimate the amount of the biological active monomeric prolactin.".

Manufacturer Narrative

The customer provided updated information related to the clinical condition of the patient.The physician stated the patient had a high prolactin 1 year ago and since then, the patient has received treatment with a prl inhibitor which corresponds to the low prolactin ii results produced by the device.The customer also clarified that the prolactin ii result of 3.01 ng/ml was obtained by peg precipitation testing.

• Brand Name: ELECSYS PROLACTIN ASSAY
• Type of Device: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7392514
• MDR Text Key: 104539744
• Report Number: 1823260-2018-01044
• Device Sequence Number: 1
• Product Code: CFT
• Combination Product (y/n): N
• PMA/PMN Number: K964748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 07027737190
• Device Lot Number: 25044300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR