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

Model Number E602

Device Problem High Test Results (2457)

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

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of an erroneous result for 1 patient sample tested for elecsys ferritin (ferritin) on a cobas 8000 e 602 module.The erroneous result was not reported outside of the laboratory.The initial result was diluted 1/50 and the result from the e602 module was 22168 ng/ml.The sample was repeated by the siemens method and the result was 6689 ng/ml.The customer stated quality control (qc) results were within range prior to running the patient sample.The customer double-checked the results on (b)(6) 2017 and the patient results were similar to the results on (b)(6) 2017.Qc results were within range on both the roche system and the siemens system.There was no allegation that an adverse event occurred.The ferritin reagent lot number was 20990800 with an expiration date of 31-may-2018.

Manufacturer Narrative

The customer did not think the roche result was wrong.The high result above the expected range fit the patient's clinical picture.The customer was confused by the difference between the roche and siemens results which were obtained approximately 3 hours apart.There were no visible clots in the sample.

Manufacturer Narrative

The initial report stated: "the customer stated quality control (qc) results were within range prior to running the patient sample." the customer clarified this as: the customer stated quality control (qc) results were within range approximately 30 minutes after running the patient sample." a review of the customer's pre-analytical data do not suggest a handling issue.Since qc results were acceptable, a general reagent issue is not suspected.

Manufacturer Narrative

No issues were identified during a review of the alarm trace.

Manufacturer Narrative

The customer provided instrument performance testing data from (b)(6) 2017.The date of event was (b)(6) 2017.The data from (b)(6) 2017 show that results for one test were out of specification.Since this data is from (b)(6) 2017, it does not reflect the current status of the instrument.A specific root cause was not identified.Additional information was requested for investigation but was not provided.

• 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: 6854523
• MDR Text Key: 85905726
• Report Number: 1823260-2017-01937
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• 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: 63 YR