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

Model Number C501

Device Problem Low Test Results (2458)

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

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer obtained a questionable low result for one neonate patient sample using the bilt3 bilirubin total gen.3 (bilt3) assay on the cobas 6000 c (501) module.All result are in units of umol/l.The initial result was released outside the laboratory.No data flags or alarms occurred.The initial result from a microcup was 13.1.The clinician rejected this result and asked for it to be repeated.The repeat result was 286.1.The sample's appearance made this result more plausible.There was no allegation that an adverse event occurred.The bilt3 reagent lot number was 221231 with an expiration date of 10/30/2018.Calibration and quality controls were acceptable; therefore, a general reagent issue could be excluded.The customer has not had issues with any other assays.The field service representative checked the cell wash settings, sodium hydroxide consumption, carry-over settings, gear pump pressure, tubing installation, and sample and reagent needle wash; all were acceptable.He ran a precision check which passed.The alarm log showed no issues.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The most likely root cause was an isolated sample-related issue.The issue did not recur.

• 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: 6835067
• MDR Text Key: 86281003
• Report Number: 1823260-2017-01875
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Health Professional
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• 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