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 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer complained of a discrepant result for elecsys prolactin assay on one patient sample.The initial prolactin result was 0.274 ng/ml and was obtained on (b)(6) 2017.The same sample was repeated on (b)(6) 2017 with a result of 12.24 ng/ml.Later on (b)(6) 2017 the customer performed a new calibration and qc testing for prolactin.The patient sample was again tested for prolactin and a result of 11.95 ng/ml was obtained.The initial result was reported outside of the laboratory.The repeat results were deemed to be correct.There was no allegation of an adverse event.The prolactin reagent lot was 24861501 with an expiration date of 31-oct-2018.Further investigation concluded that a reagent issue is excluded since both calibration and qc were acceptable.A possible root cause was attributed to pre-analytical handling and human error.The customer was not using the recommended rack adapters and an insufficient amount of patient sample was drawn.A sampling error was also generated by the analyzer around the time of event.

Manufacturer Narrative

Device available for eval was updated.

• 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: 6961336
• MDR Text Key: 90699545
• Report Number: 1823260-2017-02376
• Device Sequence Number: 0
• Product Code: CFT
• 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
• Type of Report: Initial,Followup
• Report Date: 11/01/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1