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

Catalog Number 05990378001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for three patient samples tested for thyrotropin (tsh) on the e602 analyzer.The erroneous results were reported outside of the laboratory.The customer states that samples will recover high and then are automatically diluted by the analyzer resulting with low values.When samples are repeated again with a dilution, the results are higher and considered good values.The first sample initially resulted as > 100 mu/l accompanied by a data flag.The sample is then automatically repeated by the analyzer at a 1:10 dilution, resulting as 75.89 mu/l.The sample was repeated on (b)(6) 2016 at a 1:10 dilution, resulting as 54.54 mu/l.The sample was also repeated on (b)(6) 2016 without a dilution, resulting as 65.16 mu/l.The second sample initially resulted as > 100 mu/l accompanied by a data flag on (b)(6) 2016.The sample is then automatically repeated by the analyzer at a 1:10 dilution, resulting as 3.62 mu/l.The sample was repeated on (b)(6) 2016 at a 1:10 automatic dilution, resulting as 152.5 mu/l.The third sample initially resulted as > 100 mu/l accompanied by a data flag on (b)(6) 2016.The sample is then automatically repeated by the analyzer at a 1:10 dilution, resulting as 0.202 mu/l.The sample was repeated on (b)(6) 2016 at a 1:10 automatic dilution, resulting as 121.3 mu/l.The patients were not adversely affected.The tsh reagent lot number was 124433.The reagent expiration date was asked for, but not provided.

Manufacturer Narrative

The customer stated that the laboratory humidity is too low.They have since corrected this and have had no further problems since doing this.A specific root cause could not be determined based on the provided information.A general reagent issue can be excluded since quality controls were found to be within specified ranges.The most likely reason for the low results was premature liquid level detection due to low air humidity.

• 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: 5637024
• MDR Text Key: 44615418
• Report Number: 1823260-2016-00608
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Type of Report: Initial,Followup
• Report Date: 06/06/2016

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?: No
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2016
• 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