MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they failed their last two proficiency surveys for a1c-3 tina-quant hemoglobin a1c gen.3 (hba1c) on the cobas 6000 c (501) module - c501.The last failure that occurred with the proficiency testing was in (b)(6) 2017.The customer also stated that they tested seven patient samples for hba1c and then sent these to a sister laboratory for repeat testing.Of these seven samples, two had erroneous hba1c results that were reported outside of the laboratory.The customer stated the calibrator lot number installed in the analyzer software when they ran the proficiency samples in november was lot 183640.However, they discovered they were actually using calibrator lot number 187765 when testing the proficiency samples.On (b)(6) 2017, the customer corrected the calibrator lot number programmed in the software to a new lot number, 126358.The customer calibrated both reagent packs that were on board the analyzer, but received a short sample alarm when testing with one pack.The customer removed both packs and loaded a new reagent pack.The customer calibrated this new reagent pack with the new calibrator lot number (126358) and received a calibration error.The customer then re-calibrated and the calibration was successful.Quality controls were within range.The patient samples were initially tested on the customer's c501 analyzer on (b)(6) 2017 and these initial results were reported outside of the laboratory.The repeat results from a sister site on (b)(6) 2017 were believed to be correct.Patient sample 1 initially resulted as 7.4 % on the customer's c501 analyzer and repeated as 6.8 % at the sister site.After calibrating the new pack with the newly installed calibrator on (b)(6) 2017, the customer repeated the sample and it resulted as 7.4 %.Patient sample 2 initially resulted as 7.7 % on the customer's c501 analyzer and repeated as 7.1 % at the sister site.After calibrating the new pack with the newly installed calibrator on (b)(6) 2017, the customer repeated the sample and it resulted as 7.6 %.The patients were not adversely affected.The customer did not notify anyone of the result differences and no corrected reports were issued.Quality controls were within range and there were no complaints about patient results.The hba1c reagent lot number was 25332701, with an expiration date of 31-jan-2017.All other tests performed on the analyzer were ok.The field service engineer determined that the new calibrator lot number had not been downloaded into the analyzer software and the lot number that was in the system expired april 2017.He downloaded the correct lot number into the system software and calibrated a new cassette.He ran patient correlation studies with another c501 analyzer at another site.

Manufacturer Narrative

Investigations determined that since the incorrect calibrator lot information was downloaded into the system software at the time of the event, calibrations were being run with the wrong set points.The issue was resolved after downloading the information for the correct lot number into the system software.

• Brand Name: COBAS 6000 C501 MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7181595
• MDR Text Key: 97858105
• Report Number: 1823260-2018-00119
• Device Sequence Number: 0
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2017
• 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