MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E601 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number 04745922001

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable igg antibodies to rubella virus results for an unknown number of patient samples.Of the data provided for four patient samples, only the results for two patient samples were discrepant.The specific date of testing was not provided.Patient 1 result from cobas e601 was 5.25 iu/ml (non-reactive).The result for the same sample tested on a mini vidas was 31.Patient 2 result from cobas e601 was 7.77 iu/ml (non-reactive).The result for the same sample tested on a mini vidas was 23.The results from the cobas e601 were reported outside the laboratory.No adverse event was reported.The reagent lot number was 182963.The expiration date was requested, but was not provided.

Manufacturer Narrative

The samples were submitted for investigation and the customer's results were reproduced.No reagent specific issue could be found.

Manufacturer Narrative

Further investigation of the submitted samples confirmed the true result for the samples to be positive.A specific root cause for discrepancy could not be determined.

Manufacturer Narrative

Additional information was received that the date of the event was actually (b)(6) 2015.The unit of measure for the repeat results on the vidas analyzer was iu/ml.Patient 1 was repeated on (b)(6) 2015.Patient 2 was repeated on (b)(6) 2015.The repeat result was actually 24 iu/ml.Patient 2 was a (b)(6) year old female.

• Brand Name: COBAS 6000 E601 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: 5047845
• MDR Text Key: 24789113
• Report Number: 1823260-2015-04057
• Device Sequence Number: 0
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: Health Professional
• Report Date: 10/13/2015

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: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• 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: 036 YR