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 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer initially stated that electrodes and tubing were replaced by the field service engineer on 03/10/2017 as part of preventive maintenance for the cobas 6000 c (501) module - c501 analyzer.The customer stated that erroneous initial results were reported outside of the laboratory for 8 patient samples tested for ise indirect ci for gen.2 (chloride) on (b)(6) 2017.These samples were repeated on the same analyzer and the repeat results were believed to be correct.Refer to the attachment for all patient data.The patients were not adversely affected.The chloride electrode lot number and expiration date were asked for, but not provided.On (b)(6) 2017, the customer stated that they were having calibration issues with the ise tests on the c501 analyzer on (b)(6) 2017.The customer calibrated the analyzer since multiple patient samples were showing decreased anion gap results.The customer replaced the potassium chloride system reagent and re-calibrated.Calibrations looked better.Controls and patient results were testing well.The customer has a low throughput of testing on the analyzer.Internal standard and diluent system reagents had been on board the analyzer for a while and were getting low.The customer also stated that the humidity in their laboratory was low.The customer was advised that humidity outside of analyzer specifications can cause evaporation of system reagents.The customer was advised to replace the system reagent bottles, perform a prime, run an ise check 30 times, and then recalibrate.The customer stated that controls were drifting on (b)(6) 2017 and this was resolved by replacing the system reagents and re-calibrating.The customer declined a service visit.A specific root cause could not be determined based on the provided information.

• 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: 6496811
• MDR Text Key: 72879322
• Report Number: 1823260-2017-00790
• Device Sequence Number: 0
• Product Code: CGZ
• 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
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/17/2017
• 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
• Patient Sequence Number: 1
• Patient Age: 71 YR