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 06/13/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer checked both analyzers.Gear pump pressures and probe alignments were checked.The issue was suspected to be related to the reagent.A new bun reagent lot was loaded and the issue was resolved.On c 501 serial number (b)(4), the field service engineer found a misadjusted syringe locking screw.The screw was adjusted.Cell rinse volumes were adjusted.Precision studies were performed and met specifications.The customer ran calibration and controls; results met the customer's specifications.The last calibration performed on (b)(6) 2020 for c 501 serial number (b)(4) was ok.Quality controls were within range on this analyzer, showing no indication of a reagent performance issue.The investigation determined the service actions resolved the issue for analyzer serial number (b)(4).For analyzer serial number (b)(4), the investigation could not identify a product problem.The cause of the event on this analyzer could not be determined.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with ureal urea/bun on two cobas 6000 c (501) module analyzers.The reporter stated that the bun calibration is drifting, as the controls were going outside of range.The reporter noted that a new lamp was installed on c501 serial number (b)(4) on (b)(6) 2020 and the lamp reading was unusually low.The sample initially resulted with a bun value of 81 mg/dl accompanied by a data flag when tested on c501 analyzer serial number (b)(4).This value was reported outside of the laboratory and questioned by a doctor.The sample was repeated on c 501 analyzer serial number (b)(4), resulting with a bun value of 80 mg/dl.The assay was re-calibrated and repeated on c 501 analyzer serial number (b)(4), resulting with a value of 28 mg/dl on (b)(6) 2020.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10238853
• MDR Text Key: 202940014
• Report Number: 1823260-2020-01609
• Device Sequence Number: 1
• Product Code: CDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 04460715190
• Device Lot Number: 46026801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR