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

Catalog Number	09315276160
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 65183400 with an expiration date of 31-mar-2024.The field service engineer (fse) inspected the analyzer and verified that it was functioning properly.He also checked the voltage for the sample probe.The customer performed a precision test with successful results.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys probnp ii stat immunoassay result from one patient sample tested on a cobas 6000 e601 module.The initial result was reported to the medical personnel who requested a rerun of the patient sample.On (b)(6) 2023, the initial result was 36.00 pg/ml with a data flag.On 04-aug-2023, the repeat result was 16932 pg/ml.
Additional Manufacturer Narrative
The issue was not resolved.On the field service engineer's (fse) second service visit, he again inspected the module and found the sample probe voltage to be too high, the probe contacts were degraded, and the extra wash station (ews) nozzle alignments were not in the proper positions.The fse replaced the sample probe, set the voltage to the correct specification, adjusted the ews nozzles, and cleaned the ews drain with bleach water.The fse performed mechanical checks and serial testing of the reported sample with successful results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS E 601 MODULE
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17654855
• Report Number: 1823260-2023-02827
• Device Sequence Number: 15298855
• Product Code: JJE
• UDI-Device Identifier: 07613336191576
• UDI-Public: 07613336191576
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 09315276160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female