MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 IMMUNOASSAY ANALYZER; IMMUNOCHEMISTRY ANALYZER

Model Number E411 RACK

Device Problem Low Test Results (2458)

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

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of a low erroneous result for 1 patient sample tested for elecsys prolactin assay (prolactin) on a cobas e 411 immunoassay analyzer.The initial result was 0.076 ng/ml.This result was reported outside of the laboratory.The sample was repeated and the result was 15.55 ng/ml.This result was also reported outside of the laboratory.Quality control (qc) results were within the acceptable range.There was no allegation that an adverse event occurred.The prolactin reagent lot number was 17223700 with an expiration date of 03/31/2018.The customer noted that there was a sample noise alarm at the same time this sample was pipetted and is wondering why there was no instrument alarm produced with the low result.The customer also stated there was wet serum on the wall of the sample container.

Manufacturer Narrative

A specific root cause was not identified.Based on the data provided, the investigation did not confirm the issue related to the customer's question as to why no instrument alarm occurred at the time of the sample noise alarm for the low prolactin result.Hitachi was provided with a failure report and concluded that the sample noise alarm was issued when the lh result was sampled.The sample noise alarm did not occur when prolactin was sampled, therefore no data alarm was issued for the prolactin results.Potential root causes for the low prolactin result may be related to the sample adhering to the wall of the tube, the 13 mm sample tube was tilted or the rack adapter for the 13 mm tube was not set.The 13 mm tube may have been tilted and the sample that adhered to the wall of the tube was sampled accordingly.The sample/reagent probe may not have been properly adjusted.

• Brand Name: COBAS E 411 IMMUNOASSAY ANALYZER
• 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: 6767508
• MDR Text Key: 82581317
• Report Number: 1823260-2017-01602
• Device Sequence Number: 0
• Product Code: CFT
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E411 RACK
• Device Catalogue Number: 04775201001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• 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