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

Model Number E601

Device Problem Low Test Results (2458)

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

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they received erroneous results for three patient samples tested for the elecsys ft4 ii assay (ft4) on the cobas 6000 e 601 module (e601).Of the three samples, one had an erroneous result that could not be detected by the operator.The erroneous result was not reported outside of the laboratory.The sample initially resulted as 0.153 ng/dl.The sample was repeated, resulting as 1.46 ng/dl.No adverse events were alleged to have occurred with the patient.The ft4 reagent lot number was 18541401, with an expiration date of 30-nov-2017.The field service engineer and field application specialist checked the performance of the analyzer and it is working properly.Precision studies were performed using both cups and secondary tubes.Precision was precise, with no issues.The customer was using secondary tubes and the sample volume was found to be low at 800 ul.It was recommended to the customer to use cups for testing.Calibration data was within expectations, but the last calibration was performed on 27-may-2017.Re-calibration is recommended after one month according to product labeling.Calibration signals were outside of expectations on 25-mar-2017, 12-apr-2017, and 08-may-2017.One level of quality control was performed on 25-aug-2017 and was within range.The second level of control was last tested on 22-aug-2017 and was within range.The second level of control was not tested on the date of the event.A specific root cause could not be determined based on the provided information.Based on the quality control data, a general reagent issue could very likely be excluded.Possible root causes for this event may be sample quality, bubbles/foam on reagent surfaces, and insufficient maintenance.

• 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: 6865055
• MDR Text Key: 86424130
• Report Number: 1823260-2017-01985
• Device Sequence Number: 0
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2017

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: 08/25/2017
• Initial Date FDA Received: 09/14/2017
• 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