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

Model Number C501

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable mg magnesium results for 5- 6 patient samples when calibration and qc were acceptable.Of the data provided for five patient samples, only the results for four were discrepant.Patient 1 initial result was 3.46 mmol/l and the repeat result was 5.52 mmol/l.Patient 2 initial result was 3.47 mmol/l and the repeat result was 1.73 mmol/l.Patient 3 initial result was 3.47 mmol/l and the repeat result was 5.37 mmol/l.Patient 4 initial result was 3.40 mmol/l and the repeat result was 0.43 mmol/l.The erroneous results were not reported outside the laboratory.Information concerning if any patient was adversely affected was requested but it was unknown.The reagent lot number and expiration date were requested but were not provided.It was determined the gear head pressure was low.The field service representative found the wash tubing was worn and had been rubbing on the bracket and found there was calcium build up in the vacuum tube.He replaced the worn wash tubing and cleaned the calcium deposits.

Manufacturer Narrative

Follow up with the customer verified the issue was resolved by the actions taken during the service visit.The customer confirmed no patients had been adversely affected.

• 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: 6770866
• MDR Text Key: 82138287
• Report Number: 1823260-2017-01630
• Device Sequence Number: 0
• Product Code: JGJ
• 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,Followup
• Report Date: 09/06/2017

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: 07/19/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 07/19/2017
• Supplement Dates FDA Received: 09/06/2017
• 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