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

Model Number E602

Device Problem Low Test Results (2458)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable low elecsys afp assay result for one patient sample.The initial result from an aliquot was 1.41 iu/ml and was reported outside the laboratory, but the doctor did not believe the result.The repeat result from the primary sample tube on (b)(6) 2017 was 7292 iu/ml which was more in line with the patient history.The patient was admitted following an outpatient appointment.The patient was not treated based on the result and there was no allegation of an adverse event.The reagent lot number was 16120224 with an expiration date of 31-dec-2017.The measuring cells on the analyzer were replaced.

Manufacturer Narrative

A specific root cause could not be identified.Possible reasons include an air bubble or foam on the sample surface, the tube not placed straight causing false liquid level detection (lld), or an insufficient sample volume.Review of the provided calibration and qc data did not indicate a general reagent issue and the analyzer alarm trace did not indicate any issues.Follow up with the customer confirmed they had no further issues after the replacement of the measuring cells.

• 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: 6859292
• MDR Text Key: 85932824
• Report Number: 1823260-2017-01964
• Device Sequence Number: 0
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• 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?: No
• Date Manufacturer Received: 08/23/2017
• 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: 54 YR