MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AMMONIA II; ENZYMATIC AMMONIA METHOD

Catalog Number	07229593190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Hypokalemia (4825)
Date of Event	01/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The last calibration performed on 17-jan-2023 was acceptable with no alarms.Provided quality control data was incomplete and could not be assessed.The field service engineer checked the analyzer and found a hole in the vacuum line of the rinse mechanism nozzle, a second nozzle was clogged.He corrected the issues and adjusted the water volume.The customer ran calibration and quality control results.Instrument performance testing and mechanical checks were performed and passed within specifications.The investigation determined the service actions performed resolved the issue.
Event or Problem Description
The initial reporter alleged that they received high results on a run of "about" 14 patient samples tested with the nh3l2 (ammonia ii) assay on a cobas 6000 c501 module, serial number (b)(4).It was reported that the samples were repeated on a second cobas c501 module, serial number (b)(4), resulting in lower values.Of the data provided five patient samples received discrepant results tested with the nh3l2 (ammonia ii) assay on cobas c501 modules: patient sample #2: the sample initially resulted in an nh3l2 value of 463 ug/dl.The sample was repeated on the second c501 module, resulting in a value of 30 ug/dl.A sample that was redrawn from the patient, resulted in an nh3l2 value of 28 ug/dl.Patient sample #4: the sample initially resulted in an nh3l2 value of 457 ug/dl and repeated as 81 on the second c501 module.Patient sample #5: the sample initially resulted in an nh3l2 value of 569 ug/dl and repeated as 243 ug/dl on the second c501 module.Patient sample #6: the sample initially resulted in an nh3l2 value of 145 ug/dl and repeated as 20 ug/dl on the second c501 module.Patient sample #7: the sample initially resulted in an nh3l2 value of 394 ug/dl and repated as 44 ug/dl on the second c501 module.

• Brand Name: AMMONIA II
• Common Device Name: ENZYMATIC AMMONIA METHOD
• 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: 16470997
• Report Number: 1823260-2023-00630
• Device Sequence Number: 5133431
• Product Code: JIF
• UDI-Device Identifier: 04015630936526
• UDI-Public: 04015630936526
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183517
• 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
• Report Date (Section B): 03/02/2023

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: 12/31/2023
• Device Catalogue Number: 07229593190
• Device Lot Number: 65391701
• 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: 01/31/2023
• Initial Report FDA Received Date: 03/02/2023
• 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: 77 YR
• Patient Sex: Female