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 Consequences Or Impact To Patient (2199)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for the elecsys total psa immunoassay (tpsa) on a cobas e 411 immunoassay analyzer (e411).The sample initially resulted as 0.033 ng/ml and this value was reported outside of the laboratory.The result was questioned by the doctor and a repeat of the sample was requested.The sample was retrieved from frozen storage, thawed, re-centrifuged, and repeated.The repeat result was 4.57 ng/ml accompanied by a data flag on (b)(6) 2017.The sample was also repeated on a different e411 analyzer, resulting as 4.45 ng/ml accompanied by a data flag on (b)(6) 2017.The repeat result was believed to be correct.The patient was not adversely affected.The tpsa reagent lot number was 17063400, with an expiration date of 12/31/2017.Another sample that was run in the same rack as the complained sample was repeated and the repeat result matched the original result.The customer pulled the questioned sample to inspect it while reporting the issue to roche and the sample appeared to be slightly hemolytic.The customer stated that no hemolysis was observed in the sample when it was initially run.The field service engineer could not determine a cause for the issue.He ran performance testing on the analyzer.The instrument was performing within specifications.Upon investigation of the data, the calibration signal for one of the calibrators was low, which may indicate an old measuring cell.A review of the alarm trace revealed a sample pipetting alarm indicating insufficient sample volume or a clot.No issues were seen with the quality control data.A specific root cause could not be determined based on the provided information.It is most likely that there was an incorrect aspiration of the sample based on the observed alarm.Possible root causes for this event may be sample quality and insufficient maintenance.

• 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: 6610683
• MDR Text Key: 76745706
• Report Number: 1823260-2017-01140
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• 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: 05/17/2017
• 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: 68 YR