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

Catalog Number 04460715190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).[(b)(6)].

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with crep2 creatinine plus ver.2 and ureal urea/bun on a cobas 6000 c (501) module.Values from the sample were reported outside of the laboratory to the doctor.This medwatch will apply to the bun assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the creatinine assay.Refer to the attachment for all patient data.Measurements were performed with a serum tube and a plasma tube collected from the patient at the same time.The serial number of the c 501 analyzer is (b)(4).

Manufacturer Narrative

Different reagent lots and tests are affected, therefore a reagent issue is unlikely.Calibration and controls were acceptable.The field service engineer checked the instrument and found it to be ok, so a general hardware issue is also unlikely.The reporter stated the issue occurred again one month later and it was found that the urine sample tube was full and contaminated the serum sample.To prevent such contamination, the customer stated they started not sending completely full urine tubes to the analyzer, but aliquoting part of these tubes to use for testing.Since the customer started doing this, no further issues have occurred.

• Brand Name: UREA/BUN
• Type of Device: UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10482438
• MDR Text Key: 214799386
• Report Number: 1823260-2020-02170
• Device Sequence Number: 1
• Product Code: CDQ
• Combination Product (y/n): N
• PMA/PMN Number: K972250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 04460715190
• Device Lot Number: 475906
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO MEDICATION.
• Patient Age: 13 YR