MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS BRAHMS PCT; DEVICE TO DETECT AND MEASURE PROCALCITONIN

Catalog Number 05056888200

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable results for elecsys ft4 ii assay, elecsys vitamin b12 immunoassay, elecsys folate iii assay, elecsys brahms pct, and elecsys tsh assay for one patient and suspected an interference with biotin from the qizenday treatment the patient was receiving.The customer used a cobas 6000 e 601 module.The serial number was requested but was not provided.Specific data and additional information for the complaint was requested but was not provided.Information concerning if any erroneous result was reported outside the laboratory was requested but it was unknown.The patient was not adversely affected.The complaint also involved elecsys ft4 ii assay, elecsys vitamin b12 immunoassay, elecsys folate iii assay, and elecsys tsh assay.Refer to the medwatchs with patient identifiers (b)(6) for the other assays involved.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The units of measure for the assays involved in this event were provided as follows: ft4: pmol / l.B12: pg / ml.Fol: nmol / l.Pct: ng / ml.Tsh: mu / l.Samples drawn from the patient on (b)(6) 2017, (b)(6) 2017, 01/12/2017, (b)(6) 2017, and (b)(6) 2017 were submitted for investigation.The samples were tested on a cobas e601 analyzer and a cobas e411 analyzer.Based on the results for four of the samples, an immunoglobulin that reacts with the reagent and affects the results was suspected.No interfering factor to streptavidin was found in the samples.

Manufacturer Narrative

The biotin concentration was measured in the samples provided: (b)(6).For all of the samples drawn when the patent was known to be taking the qizenday treatment, the result was higher than the allowable concentrations specified in the method sheets of all involved assays.The result for the sample from (b)(6) 2017 when the patient may have not been taking the qizenday treatment was not above the allowable concentrations.The high biotin concentration most likely caused the issue.Interference with assays that use the biotin-streptavidin technology is possible and the therapy should be stopped for one week before measurements are done.

• Brand Name: ELECSYS BRAHMS PCT
• Type of Device: DEVICE TO DETECT AND MEASURE PROCALCITONIN
• 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: 6280280
• MDR Text Key: 65849398
• Report Number: 1823260-2017-00158
• Device Sequence Number: 1
• Product Code: PMT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05056888200
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• 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: 56 YR