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

Model Number E601

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 1 patient tested for vitamin b12 ii on a cobas 6000 e 601 module.The initial vitamin b12 ii result from the e601 module was <50 pg/ml with a data flag.The sample was repeated on the e601 module and the result was 2000 pg/ml with a data flag.The sample was repeated again on the e601 module and the result was <50 pg/ml with a data flag.This result was reported outside of the laboratory where it was questioned by the physician.The patient was tested by a different laboratory on (b)(6) 2017 using the chemiluminescence method and the vitamin b12 result using a manual dilution of 1:2 was 6463 pg/ml.The patient was tested at a different laboratory on (b)(6) 2017 and the result was >2000 pg/ml.A new sample was obtained from the patient on (b)(6) 2017 and the result from the e601 module was 2000 pg/ml with a data flag.The sample was repeated on the e601 module with a 1:2 dilution and the result was 2000 pg/ml with a data flag.There was no allegation that an adverse event occurred.The vitamin b12 ii reagent lot number was 177486-01.The expiration date was not provided.It is not clear when the last valid calibration was performed.The calibration data provided was from (b)(6) 2017.Quality control data was provided, but it is not clear when the results were generated.A specific root cause could not be identified.Additional information was requested for investigation but was not provided.The low results of <50 pg/ml may be related to issues with sample quality and insufficient maintenance.The high results of >2000 pg/ml may indicate the presence of immunoglobulin-vitamin b12 complex which can cause high results, however this cannot be confirmed as the sample is not available for investigation.

Manufacturer Narrative

Analyzer performance testing was within specification.The results from the performance test do not suggest an issue related to the analyzer that would have caused the reported event.

• 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: 6631832
• MDR Text Key: 77537133
• Report Number: 1823260-2017-01209
• Device Sequence Number: 0
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

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?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 05/25/2017
• Supplement Dates FDA Received: 07/11/2017
• 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: 72 YR