MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem High Test Results (2457)

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

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for bilt3 bilirubin total gen.3 (tbil) on a cobas 6000 c (501) module - c501.It was asked, but it is not known if the erroneous result was reported outside of the laboratory.The sample initially resulted as 17.499 mg/dl accompanied by a data flag when tested on the c501 analyzer.The sample was repeated on a cobas integra 400 (i400) analyzer, resulting as 6.13 mg/dl accompanied by a data flag.The 6.13 mg/dl value matched the previous report and diagnosis of the patient.No adverse events were alleged to have occurred with the patient.The tbil reagent lot number was 20143601, with an expiration date of (b)(6) 2018.Upon review of the reaction monitor for the 17.499 mg/dl value, no issues were seen.Calibrations performed on both c501 and i400 analyzers were ok.Quality control recoveries on both analyzers were ok.No issues were seen upon review of the c501 analyzer alarm trace.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Based on the provided data, a general reagent issue could be ruled out since calibration and controls were acceptable for both analyzers.

• Brand Name: COBAS 6000 C (501) 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: 6854566
• MDR Text Key: 86846283
• Report Number: 1823260-2017-01938
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

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: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 08/22/2017
• Supplement Dates FDA Received: 10/09/2017
• 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