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

Catalog Number 05990378001

Device Problem Low Test Results (2458)

Patient Problem No Information (3190)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer initially questioned results for 21 patients tested for total (free + complexed) psa - prostate-specific antigen (tpsa) - total psa.Of the data provided, 1 patient sample was erroneous for total psa and free psa (free psa).It is not known if erroneous results were reported outside of the laboratory.The initial total psa result was 1.14 ng/ml.The repeat result was 10.5 ng/ml.The initial free psa result was 0.379 ng/ml.The repeat result was 0.829 ng/ml.The customer also provided additional results for 111 patients tested on other assays.Based on the data provided, erroneous results were identified for 68 patients tested for one or more of the following tests: prolactin (prolactin ii), free thyroxine (ft4), thyrotropin (tsh), cortisol, antibodies to thyroid peroxidase (anti-tpo), and immunoglobulin e (ige ii).It is not known if erroneous results were reported outside of the laboratory.Refer to the attachment to the medwatch for the additional patient results.It is not known if any adverse event occurred.No adverse event was reported.No reagent lot numbers or expiration dates were provided.It was noted that the measuring cell on the analyzer was last replaced on (b)(6) 2015.It was noted that the field service representative ran performance testing, performed a high voltage adjustment, and then repeated performance testing.

Manufacturer Narrative

Clarification was provided that the initial result of 1.14 ng/ml was reported outside of the laboratory.The repeat result of 10.5 ng/ml was sent as an amended result to the physician.No adverse event was reported.

Manufacturer Narrative

Based on a review of the alarm trace, it was noted that there were abnormal sipper alarms at the time of the results.The instrument recovered without any service actions being performed.The instrument was checked by the field service representative and no issues were identified.The root cause was determined to be that the procell volume was not reset properly.Quality controls were acceptable.

• Brand Name: COBAS 8000 E602 MODULE
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5260109
• MDR Text Key: 32764682
• Report Number: 1823260-2015-04651
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 11/15/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2015; 01/19/2016
• 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
• Patient Age: 62 YR