MAUDE Adverse Event Report: ROCHE DIAGNOSTICS UREAL; UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

Catalog Number	04460715190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.H3 other text : na.
Event or Problem Description
There was an allegation of questionable ureal (urea) results for eight patient samples from the cobas integra 400 plus serial number (b)(6).The questionable results were reported outside of the laboratory and were repeated on (b)(6) 2023 after the doctors queried the results.Sample (b)(6) initial result was 9.4 mmol/l and the repeat result was 5.09 mmol/l.The repeat result in a different lab was 5.31 mmol/l.Sample (b)(6) initial result was 14.1 mmol/l and the repeat result was 6.98 mmol/l.The repeat result from a different instrument was 6.62 mmol/l.Sample (b)(6) initial result was 6.9 mmol/l.The repeat results were 2.9 mmol/l and 2.95 mmol/l.Sample (b)(6) initial result was 9.0 mmol/l.The repeat results were 4.48 mmol/l and 4.44 mmol/l.
Additional Manufacturer Narrative
Based on the provided information, the investigation could not determine a specific root cause.The calibration and qc data did not show any abnormalities.

• Brand Name: UREAL
• Common Device Name: UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16852880
• Report Number: 1823260-2023-01477
• Device Sequence Number: 15347662
• Product Code: CDQ
• UDI-Device Identifier: 04015630920464
• UDI-Public: 04015630920464
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 07/17/2023

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 04460715190
• Device Lot Number: 65277101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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: 59 YR
• Patient Sex: Male