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 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of erroneous low results for 2 pediatric patient samples tested for bilt3 bilirubin total gen.3 (bilt3) on a cobas 6000 c (501) module.It is not known if erroneous results were reported outside of the laboratory.Patient 1 initial bilt3 result from the c501 module in question was 68.9 umol/l.The sample was repeated on a different c501 module and the result was 195.6 umol/l.Patient 2 initial bilt3 result from the c501 module in question was 3 umol/l.The sample was repeated on the c501 module in question and the result was 20.8 umol/l.The sample was repeated on a different c501 module and the result was 243.9 umol/l.There was no allegation that an adverse event occurred.The bilt3 reagent lot number was 221212.The expiration date was not provided.The reaction monitor provided for patient 2 indicates a pipetting error or a sample specific issue for the initial and repeat results from the c501 module in question.Quality control (qc) results were acceptable.The customer was not having problems with other assays.A specific root cause was not identified.Additional information was requested for investigation but was not provided.A general reagent problem can be ruled out since qc results were acceptable.

• 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: 6803045
• MDR Text Key: 83749785
• Report Number: 1823260-2017-01739
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 08/18/2017

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/18/2017
• 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