MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable high elecsys total psa immunoassay result for one patient sample.The initial result was 5.88 ng/ml and was reported to the patient and the doctor.As the patient had no past tpsa high result, the customer performed free psa testing with a result of 0.039.No unit of measure was provided.The patient went to his doctor, and the doctor ordered a new blood draw.On (b)(6) 2016, the tpsa result for this sample was 0.525 ng/ml.The laboratory then repeated the original sample and the result was 0.527 ng/ml.The patient was not adversely affected.The reagent lot number was 135984.The expiration date was requested but was not provided.Based on the calibration and qc data, a general reagent issue was not indicated.The centrifugation time was found to be too short which could lead to a sample quality issue and was a possible root cause.It was also found the customer was not using the recommended sample tube rack adapters which could lead to a pipetting issue.

Manufacturer Narrative

Further investigation could not determine a specific root cause.Additional information for further investigation was requested but was not provided.Based on the signal difference between the initial and repeat results, electromagnetic interference (emi) was excluded as a root cause.Possible root causes include pre-analytical issues due to insufficient sample inversions or centrifugation conditions and temporary instrument issues.

• Brand Name: COBAS 6000 E 601 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: 5997672
• MDR Text Key: 56402381
• Report Number: 1823260-2016-01516
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K060373
• 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: 10/20/2016

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 Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• 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