MAUDE Adverse Event Report: ROCHE DIAGNOSTICS UREA/BUN; UREA NITROGEN TEST SYSTEM

Catalog Number	05171873190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable alp2 alkaline phosphatase acc.To ifcc gen.2 and ureal urea/bun results for 2 patient samples on a cobas 8000 c702 module.This medwatch will cover urea.Refer to medwatch with a1 patient identifier (b)(6) for information on the alp2 results.For sample 1, the initial alp result was 9 u/l.The result did not match the patient's clinical history which prompted the customer to repeat the sample.The repeat result was 144 u/l.For sample 2, the initial urea result was 0.5 mmol/l.The result was lower than the measuring range which prompted the customer to repeat the sample.The repeat result was 11.6 mmol/l.
Additional Manufacturer Narrative
The qc recovery data provided was acceptable.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: UREA/BUN
• Common Device Name: UREA NITROGEN TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19840320
• Report Number: 1823260-2024-02176
• Device Sequence Number: 20552761
• Product Code: CDQ
• UDI-Device Identifier: 04015630925131
• UDI-Public: 04015630925131
• Combination Product (Y/N): Y
• Initial Reporter Country: EI
• PMA/510(K) Number: K972250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 05171873190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/05/2024
• 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