MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 4000 C (311) STAND ALONE SYSTEM; CLINICAL CHEMISTRY ANALYZER

Model Number C311

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of an erroneous low result for 1 patient sample tested for crpl3 c-reactive protein gen.3 (crpl3) on a cobas 4000 c (311) stand alone system.The initial crpl3 result was 0.00 mg/l with a data flag.The result was reported outside of the laboratory as <1 mg/l.The nurse noticed that this result did not correspond to the patient¿s historical results and requested the sample be repeated.The repeat result approximately an hour later was 237.34 mg/l.The patient was not treated based on the results.No adverse event occurred.The patient has been discharged from the hospital.The crpl3 reagent lot number and expiration date were not provided.The customer said only one sample was affected, they had no issues prior to the event, and as of (b)(6) 2017 had had no further issues.The field service representative (fsr) visited the customer site and noted that water rinse levels were low.These were adjusted.The sample probe was replaced and adjusted.Gear head pump pressure was increased.Quality control results were acceptable.

• Brand Name: COBAS 4000 C (311) STAND ALONE SYSTEM
• 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: 6608557
• MDR Text Key: 76666050
• Report Number: 1823260-2017-01135
• Device Sequence Number: 0
• Product Code: DCN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: C311
• Device Catalogue Number: 04826876001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• 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: 76 YR