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 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received questionable results for four patient samples tested for the elecsys afp assay (afp) and papp-a elecsys (pappa) on a cobas e 411 immunoassay analyzer (e411).Neither the papp-a reagent nor a similar reagent is available for distribution in the united states.Of the four samples, one sample had an erroneous afp result.The erroneous result was not reported outside of the laboratory.The sample initially resulted as 1.07 ug/l.The sample was repeated on (b)(6) 2017, resulting as 98.47 ug/l accompanied by a data flag.The sample was of good quality and there was no foam on the sample surface.No adverse events were alleged to have occurred with the patient.The afp reagent lot number was 17674700, with an expiration date of 10/31/2017.The field service engineer checked the customer's water quality and the analyzer liquid level detection voltage.He performed checks of the analyzer, ran performance testing, and ran blank cell calibration.Performance testing showed no issues.Precision studies were performed and were okay.

Manufacturer Narrative

Quality control results prior to the event were within specifications.Upon review of the alarm trace, two liquid level detection alarms were observed on (b)(6) 2017.The pinch valves were 8 months old, which is beyond the mandatory exchange cycle.A specific root cause could not be determined based on the provided information.Since the issue occurred with multiple assays and based on the received alarm messages, a sample pipetting error most likely occurred.The pipetting error may have been caused by pre-analytic sample handling.

• 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: 6755012
• MDR Text Key: 81497343
• Report Number: 1823260-2017-01571
• Device Sequence Number: 0
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• 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: 07/13/2017
• 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
• Patient Weight: 75