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 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for the elecsys testosterone ii assay (testo) on a cobas 6000 e 601 module (e601).The sample (collected on (b)(6) 2017) initially resulted as 8.72 ng/dl and this was reported outside of the laboratory.The physician asked for the sample to be repeated.Before repeating, the sample was re-centrifuged.The sample was repeated on a different e601 analyzer on (b)(6) 2017, resulting as 356.0 ng/dl.The sample was also repeated on the original e601 analyzer on (b)(6) 2017, resulting as 340.6 ng/dl.The repeat results were believed to be correct.The patient was not physically hurt during the event and did not receive any care based on the erroneous result.No adverse events were alleged to have occurred with the patient.The testo reagent lot number was 191053.The reagent expiration date was asked for, but not provided.The field service engineer found that there was an issue with a nozzle box assembly.He replaced the assembly.He replaced the sample probe and checked voltage.He adjusted the main pump and gear pump pressures to specifications.He adjusted the rinse stations and checked the external rinse.He adjusted the probes.He ran performance testing and precision studies.Performance testing passed within specifications.All controls were acceptable to the customer.The system was working within specifications.The field service engineer ran precision studies using the same tubes that were used for patient testing.The volume of the sample was approximately 2 ml and there was a small red cell button observed at the bottom of the sample.

Manufacturer Narrative

The testo reagent lot number has been confirmed as 19105304, with an expiration date of 02/28/2018.

• 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: 6753319
• MDR Text Key: 81524761
• Report Number: 1823260-2017-01566
• Device Sequence Number: 0
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 08/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• 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
• Date Manufacturer Received: 07/12/2017
• 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: 62 YR