MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER

Model Number E601

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

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

Event Description

The customer obtained a questionable low test result for one patient sample using the elecsys ca 19-9 immunoassay (ca 19-9) on the cobas 6000 e 601 module. All results are in units of u/ml. No results were released outside the laboratory. No data flags or alarms occurred with the results. The initial result was 34. 17. The repeat result was 6. 10. On (b)(6) 2017, a new sample was requested with a result of 36. 80. There was no allegation that an adverse event occurred. The ca 19-9 reagent lot number is 193941; the expiration date was 05/2018. Calibration and quality controls were acceptable; therefore, a general reagent problem could be excluded. A specific root cause for this event could not be identified. Additional information was requested for investigation but was not provided. Possible root causes for the non-reproducible low test result were bubbles or foam on the sample or reagent surface, and insufficient pre-analytical handling practices.

• Brand Name: COBAS 6000 E 601 MODULE
• Type of Device: IMMUNOCHEMISTRY 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: 6807475
• MDR Text Key: 83691049
• Report Number: 1823260-2017-01777
• Device Sequence Number: 0
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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

• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/21/2017
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/02/2017
• 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