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 Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer received a questionable high elecsys ferritin result from cobas 6000 e 601 module serial number (b)(4) for one patient sample that was aliquoted by the modular preanalytic analyzer (mpa) serial number (b)(4).The initial result was 75114 mcg/l with a data flag.The repeat result on the same analyzer was 128.9 mcg/l and the result on another cobas 6000 e 601 module was 126 mcg/l.The erroneous result was reported outside the laboratory.The repeat result was believed to be correct.The patient was not adversely affected.The reagent lot number was 19215405 with an expiration date of 2/28/2018.The field service representative could not find a cause.He straightened the bead mixer, checked the fluidics, and ran precision testing with results within guidelines.Refer to the medwatch with patient identifier (b)(6) for the modular preanalytic analyzer (mpa).

Manufacturer Narrative

After further investigation, a specific root cause could not be identified.Follow up confirmed the issue had not recurred after the service visit.

• 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: 6702927
• MDR Text Key: 80075924
• Report Number: 1823260-2017-01447
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• 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
• Patient Age: 32 YR