MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer initially complained of questionable results for an unspecified number of patient samples tested for roche diagnostics cobas elecsys anti-tpo (anti-tpo) on a cobas 8000 e 602 module (e602).Upon further investigation, it was determined that all samples tested on measuring cell 2 for multiple assays were affected.The customer confirmed that all results from measuring cell 1 were correct.Controls from the morning of (b)(6) 2017 were correct, but it was between these times that patient samples were affected.The customer was advised that the cell may have been partially clogged during the day.It was recommended to the customer to perform liquid flow cleaning maintenance and run quality controls before repeating the patient samples.The customer provided data for a total of 5 patient samples tested for multiple assays.Of these, 4 had erroneous results for anti-tpo, the elecsys vitamin d assay (vitd), and elecsys pth immunoassay (pth).No erroneous results were reported outside of the laboratory.The first sample initially resulted with an anti-tpo value of 217 iu/ml.The sample was repeated twice on (b)(6) 2017, resulting as 29 iu/ml and 26 iu/ml.The second sample initially resulted with an anti-tpo value of 192 iu/ml.The sample was repeated twice on (b)(6) 2017, resulting as 31 iu/ml and 25 iu/ml.The third sample initially resulted with a vitd value of 124 nmol/l.The sample was repeated on (b)(6) 2017, resulting as 76 nmol/l.The fourth sample initially resulted with a pth value of 1.71 pmol/l.The sample was repeated on (b)(6) 2017, resulting as 3.29 pmol/l.No adverse events were alleged to have occurred with the patients.The lot numbers and expiration dates of the anti-tpo, vitd, and pth reagents were asked for, but not provided.It was confirmed that the issue has been solved after the customer performed the liquid flow cleaning maintenance.

• Brand Name: COBAS 8000 E 602 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: 6965205
• MDR Text Key: 90773987
• Report Number: 1823260-2017-02385
• Device Sequence Number: 0
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1