MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 IMMUNOASSAY ANALYZER; IMMUNOCHEMISTRY ANALYZER

Catalog Number	04775201973
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 411 rack cu is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys hcg+b result from one patient sample tested on the cobas e411 rack cu.The initial result was auto-verified and was reported outside of the laboratory.The result was corrected quickly as the reporter knew that the patient had a pregnancy status and a point of care (poc) test was positive.The reporter used the same plasma tube and another serum sample tube from the patient for the reruns.The initial result of the plasma sample was 2 miu/ml.The first repeat result from the plasma sample was >10,000 miu/ml.The second repeat result from the serum sample was >10,000 miu/ml.The repeat results were deemed correct. .
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the calibrations performed on 21-sep-2023 (before the event) and 26-nov-2023 (after the event); the results were within specifications.The investigation reviewed the qc recovery; the qc qc recovery was within the customer¿s established ranges.There was no indication of a performance issue with the reagent.The investigation reviewed the customer's handling of patient samples; the patient sample was centrifuged at 3600 rpm for 5 minutes.The centrifugation time may be too short and the speed may be too high as per the tube manufacturer¿s recommended guidelines.On the field service engineer's (fse) initial service visit, he inspected the analyzer and could not find a cause for the issue but noted that the measuring cells were aged.He also noted that the customer stated that sample quality/integrity was questionable because the staff who ran the reported patient sample was inexperienced.On the fse's follow-up service visit, he replaced the measuring cells.He verified the analyzer's performance by mechanical, instrument, and precision checks.The customer performed calibrations and qcs.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS E 411 IMMUNOASSAY ANALYZER
• 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: 18165131
• Report Number: 1823260-2023-03667
• Device Sequence Number: 6541862
• Product Code: JJE
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): Y
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K961481
• 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): 02/29/2024
• 2 Devices were Involved in the Event: 1 2

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: 04775201973
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 02/29/2024
• 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 Sex: Female