MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROCELL M; GENERAL PURPOSE REAGENT

Catalog Number 04880340190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained that quality control was not acceptable for multiple tests after the customer changed to a new lot of procell on all four of their cobas 8000 e 602 modules used on two lines.(b)(4).The customer stated that they had been using procell lot 28648701 before the problem occurred with the new lot of procell.The customer changed procell and cleancell and the problem continued.The customer tested multiple patient samples prior to the unacceptable quality control.Please see the attachment to this medwatch for relevant erroneous patient data.The erroneous results were reported outside of the laboratory and the customer informed the physicians regarding the erroneous results.There was no allegation of an adverse event.On (b)(6) 2017 the customer received quality control flags on both lines of the e 602 module with the new lot of procell.The customer changed the procell reagent with a different lot and quality control was acceptable.The different procell lot number was 28648701.

Manufacturer Narrative

The retention procell and the customer's procell was tested with multiple assays on the cobas 8000 e 602 module during the investigation.For the retention procell lot 276477 all of the quality control was acceptable.For the customer's procell lot 276477 the quality control was mostly out of range and produced errors and alarms.

Manufacturer Narrative

Na.

• Brand Name: ELECSYS PROCELL M
• Type of Device: GENERAL PURPOSE REAGENT
• 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: 7120797
• MDR Text Key: 95770247
• Report Number: 1823260-2017-02953
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04880340190
• Device Lot Number: 276477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 11/28/2017; 11/28/2017
• Supplement Dates FDA Received: 12/28/2017; 01/16/2018
• 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