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

Model Number C501

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable calcium result for one patient sample.The initial result was 3.33 mmol/l and was sent to the doctor who did not believe the high result.On (b)(46 2017, a new sample was drawn and the result was 2.22 mmol/l.On (b)(6) 2017, the sample from (b)(6) 2017 was repeated and the result was 2.49 mmol/l.The patient was not treated and there was no adverse event.The reagent lot number and expiration date were requested but were not provided.Based on the amount of the discrepancy, reagent carryover was suspected.

Manufacturer Narrative

Reagent issues can be excluded as a root cause.A specific root cause could not be identified.As the customer had no further issues, the issue was confirmed to be resolved by the actions with the extra wash cycles and the cuvettes.

Manufacturer Narrative

The extra wash cycles (ews) programmed on the analyzer were checked and the customer changed the cuvettes.The customer has not reported any further issues.

• 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: 6660250
• MDR Text Key: 78399131
• Report Number: 1823260-2017-01305
• Device Sequence Number: 0
• Product Code: CJY
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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,Followup
• 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: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 06/07/2017; 06/07/2017
• Supplement Dates FDA Received: 07/27/2017; 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