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 05/14/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys brahms pct (pct) on a cobas e 411 immunoassay analyzer (e411).It was asked, but it is not known if an erroneous result was reported outside of the laboratory.The sample initially resulted as > 100 ng/ml.The sample was diluted x10 and repeated three times, resulting as 5.8 ng/ml, 5.8 ng/ml, and 5.5 ng/ml.The sample was repeated on (b)(6) 2017, resulting as 80.64 ng/ml.The sample was also diluted x10 and repeated on (b)(6) 2017, resulting as 5.8 ng/ml.No adverse events were alleged to have occurred with the patient.The e411 analyzer serial number was (b)(4).

Manufacturer Narrative

An update of the repeat results that were obtained at the customer site was provided.The sample was provided for investigation, where it was tested on a cobas e 411 immunoassay analyzer.The sample was measured without dilution and after dilution with both multiassay diluent and pct negative patient serum.The e411 analyzer used for investigation was serial number (b)(4).Pct reagent lot number 203580, with an expiration date of april 2018 was used on this analyzer.The customer results could not be reproduced.The results of the diluted sample obtained during investigations was much higher than those obtained by the customer.The reason why the customer obtained much lower results in dilutions must be related to an unknown local issue within the customer lab.Per product labeling, only samples with results that are outside of the measuring range (>100 ng/ml) should be diluted.The low recovery with diluted sample measurements in the investigation can be attributed to dilutions performed outside of product labeling recommendations.

• 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: 6604367
• MDR Text Key: 76429010
• Report Number: 1823260-2017-01120
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• 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: 203580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2017
• 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