MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for one patient sample tested for antibodies to thyroid peroxidase (anti-tpo) on an e602 analyzer.It was asked, but it is not known if an erroneous result was reported outside of the laboratory.The sample initially resulted as 600.0 iu/ml accompanied by a data flag on the e602 analyzer.The sample was then manually diluted 1:5 and repeated on the e602 analyzer, resulting with a raw value of 270.6 iu/ml.When taking the dilution factor into account, the final repeat dilution result was 1353 iu/ml.The sample was repeated on an e411 analyzer in a different laboratory, resulting as 558 iu/ml.The sample was also repeated in a second laboratory on a vidas analyzer, resulting as 627 iu/ml.The patient was not adversely affected.The anti-tpo reagent lot number and expiration date were asked for, but not provided.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Low calibration signals and low control values were observed, but is most likely not the root cause of the issue.Frequent aspiration and sample short alarms were noted to have occurred.These alarms may indicate an issue with the sample, including use of smaller diameter tubes without using recommended rack adapters and/or clots/fibrin in the sample due to pre-analytic handling conditions.As noted in product labeling, autoantibodies (such as anti-tpo antibodies) are heterogeneous, and non-linear dilution effects can occur.All values were noted to be clearly above the cutoff value for the anti-tpo assay.If absolute values of results for the anti-tpo assays from different suppliers are compared, care needs to be taken in interpretation of these results.The reactivity of autoantibodies (such as anti-tpo) varies in different tests because of the use of different assay formats, detection antibodies, antigen formulations, and different incubation times.

• Brand Name: COBAS 8000 E602 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: 5660521
• MDR Text Key: 45335723
• Report Number: 1823260-2016-00648
• Device Sequence Number: 0
• Product Code: JZO
• Reporter Country Code: BE
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• 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: 04/29/2016
• 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