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

Model Number C501

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable results for four patient samples over several days.Data was only provided for a questionable total bilirubin result for one patient sample.The initial result from a microcup was 0.26 mg/dl.The repeat result from the microcup was 1.38 mg/dl.This result was reported outside the laboratory and was questioned by the doctor.A new sample was collected from the patient and tested on another cobas 6000 c (501) module in a hitachi sample cup with a result of 16 mg/dl.The patient was not adversely affected.The reagent lot number and expiration date were requested but were not provided.The customer performed correlations between the two instruments using the sample cups and they correlated well.The customer tested additional patient samples and qc material for troubleshooting and received incorrect results when the samples were tested in the microcups.The customer checked the sample probe and it was okay.The field service representative found there was an issue with the probe.He replaced and adjusted the sample probe, cleaned and lubricated the rack track, and replaced the sample syringe seals.He ran mechanism checks and diagnostic checks with results within specifications.The customer performed calibration and controls with results within specifications.

• 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: 6652924
• MDR Text Key: 78190282
• Report Number: 1823260-2017-01279
• Device Sequence Number: 0
• Product Code: MQM
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/20/2017

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: 06/06/2017
• Initial Date FDA Received: 06/20/2017
• 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: 7 DA