MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS BRAHMS PCT; DEVICE TO DETECT AND MEASURE PROCALCITONIN (PCT) IN HUMAN CLINICAL SPECIMENS

Catalog Number 05056888200

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received questionable elecsys brahms pct (procalcitonin) results from a cobas 8000 e801 module.The analyzer serial number was requested but was not provided.The customer said the issue occurred with 10 out of 1000 samples per month.The customer used serum, edta plasma, and citrate plasma from the patient and retested the samples after several hours.The customer also tested the samples by sqh method and retested after addition to a coagulation acceleration tube (thrombin + heparin neutralizing agent).The customer also performed experiments of mixing several samples which showed procalcitonin increase.No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The customer speculated that anti-procalcitonin antibody may be causing agglutination with serums contain high micro-fibrin.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.Roche has informed the customer of possible discrepancies with procalcitonin results between the cobas e801 and other roche analyzers and advised the customer to discontinue testing on the cobas e801.A recall was initiated.

• Brand Name: ELECSYS BRAHMS PCT
• Type of Device: DEVICE TO DETECT AND MEASURE PROCALCITONIN (PCT) IN HUMAN CLINICAL SPECIMENS
• 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: 7095868
• MDR Text Key: 95736813
• Report Number: 1823260-2017-02870
• Device Sequence Number: 1
• Product Code: PMT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• 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: 204084
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• 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
• Removal/Correction Number: RES 79462
• Patient Sequence Number: 1