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

Model Number E601

Device Problem High Test Results (2457)

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

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for the elecsys ca 15-3 ii assay (ca 15-3) on the cobas 6000 e 601 module (e601).The sample initially resulted as 30.08 u/ml.On (b)(6) 2018, the test was calibrated and control results were within range.The sample was then repeated on (b)(6) 2018, resulting as 32.51 u/ml.The 32.51 u/ml value was reported outside of the laboratory.The results was considered to be too high by the physician, so the sample was sent to another laboratory for testing on a cobas 8000 e 602 module (e602).The result from the e602 analyzer was 24 u/ml.The sample was tested a third time on the customer's e601 analyzer on (b)(6) 2018, resulting as 33.16 u/ml.No adverse events were alleged to have occurred with the patient.The first sample measurement performed on the e601 analyzer was measured with ca 15-3 reagent lot number 187902.The second and third sample measurements performed on the e601 analyzer were measured with ca 15-3 reagent lot number 209900.The reagent expiration dates were asked for, but not provided.

Manufacturer Narrative

Calibration and controls were within range.A general issue with reagent or calibration is unlikely.Other sample measurements compared with results measured in another laboratory.The analyzer was found to be working within specifications.The investigation was unable to find a definitive root cause.

• Brand Name: COBAS 6000 E 601 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7330272
• MDR Text Key: 102446330
• Report Number: 1823260-2018-00758
• Device Sequence Number: 0
• Product Code: MOI
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/21/2018
• Patient Sequence Number: 1