MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 402 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	09793020001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 755973.The expiration date was not provided.The serial number of cobas a is (b)(6).The serial number of cobas b is (b)(6).The customer stated that the low results were due to over-dilution of the patient sample caused by a pipetting error during the initial manual dilution process.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys procalcitonin v2 results from one patient sample tested on two cobas pure e 402 analytical unit - emc (cobas a and cobas b).The initial result of the undiluted patient sample from cobas a was >100 ng/ml with a data flag.The initial result of the undiluted patient sample from cobas b was >100 ng/ml with a data flag.The repeat result with the patient sample at 1:4 manual dilution from cobas a was 14.1 ng/ml with a final calculated dilution result of 56.4 ng/ml.The repeat result with the patient sample at 1:4 manual dilution from cobas b was 14.0 ng/ml with a final calculated dilution result of 56 ng/ml.The reporter performed an additional rerun and sent the patient to another laboratory for investigation: the repeat result with the patient sample at 1:4 manual dilution from cobas a was 23.9 ng/ml with a final calculated dilution result of 95.6 ng/ml.The repeat result with the patient sample at 1:4 manual dilution from another laboratory was 23.2 ng/ml with a final calculated dilution result of 92.8 ng/ml.This result was deemed correct and reported.The reporter stated that the initial results were not reported outside the laboratory.The patient samples were rerun because the initial and repeat results did not match and the differences were too high.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on 13-aug-2024 and the qc recovery; the results were within specifications.The investigation reviewed the alarm trace; no issues were noted.The customer confirmed the event was due to patient sample quality and not an analyzer issue.The investigation determined the customer's actions (confirmed the event was due to patient sample quality) resolved the issue.The investigation did not identify a product problem.

• Brand Name: COBAS E 402 ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY 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
• MDR Report Key: 20250547
• Report Number: 1823260-2024-02697
• Device Sequence Number: 20674038
• Product Code: JJE
• UDI-Device Identifier: 07613336220139
• UDI-Public: 07613336220139
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• 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): 10/24/2024

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: 09793020001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown